POSITION SUMMARY

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to a Manager, Cell Therapy Manufacturing at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

Department Description:

Manufacturing of cell therapy products.

Position Summary:

Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Master core responsibilities of a Manufacturing Associate I.
• Able to generate an effective production schedule.
• In addition to being fully qualified in MACI or Epicel, train and qualify in at least three core competencies, e.g. 3T3, Media Prep, GP, TrackWise, Preactor, TeamShare, QT.
• Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

Leadership qualifications include, among other requirements:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as a role model for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Biotechnology certificate with 6+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry or 8+ years of cGMP experience with GED or equivalent.
• Bachelor’s or higher degree (Life Sciences or related field) or equivalent with 4+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry.
• Excellent communication skills, written and verbal.
• Experience with Microsoft Office suite.

Preferred Qualifications:

• Experience in small scale tissue culture processing.
• Experience working within a regulated environment that is frequently audited by internal and external Agencies, such as the FDA and ISO.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• May be required to sit for long periods of time while performing cell culture operations.
• Must be able to lift, carry, push and pull up to 50 lbs.
• Ability to work 1 weekend day.
• Rotating holiday coverage.
• Ability to gown and gain entry to manufacturing areas.

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Burn Care professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Director, Regional Sales at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Front line, commercial position responsible for providing support in the procurement of Vericel products and the management of cases from biopsy through surgical procedures and ultimate discharge of burn patients. Also responsible for providing guidance, support, and input regarding optimal Epicel utilization for care of appropriate burn patients within existing accounts.

ESSENTIAL FUNCTIONS

Core Responsibilities:

Provide clinical support for patients receiving Vericel products:

• Full engagement in and intimate knowledge of the care of Vericel burn patients from admission through discharge.
• Support during various Operating room procedures for each Epicel patient.
• Awareness of and impact on burn centers’ evolving patient population.
• Knowledge of various burn product utilization protocols.
• Train and support all appropriate staff in active accounts and select prospect accounts.

• Knowledge of all procedures associated with Epicel.
• Supplies compatible and not compatible with Epicel.
• Coordinate & lead surgical skills training programs associated with Epicel.
• Foster development of Key Opinion Leaders (KOLs).
• Educate key decision makers, including surgeons and support personnel, on Epicel in partnership with BTS team.

Leadership qualifications include, among other requirements:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

• Bachelor’s or Master’s degree.
• 3 to 5+ years of experience with the care of severe burn patients.
• Experience with hospital operating room environments.
• A professional approach that sees patient welfare as the highest priority, with a strong drive to connect our products and services with every patient who will benefit.
• Expertise and personality to quickly earn trusted advisor status with key accounts and stakeholders, including top burn experts.
• Strong clinical and scientific acumen, particularly in burns or wound care, with ability to leverage in training top burn experts and support staff.
• Ability to thrive in a cross-functional team.
• Ideal Location: CA

Preferred Qualifications:

• Continuous training on technical and product knowledge.

• Continuous focus on development of personal and interpersonal skills, such as teamwork, time management, listening, trust and integrity, and work/life balance
• Strategic agility: ability to align individual business strategy with corporate goals, keen business acumen, problem solving, being innovative and thinking big picture.
• Drive for results: appropriate resource utilization, focus on fundamentals, utilize established best practices, leverage internal support, and take risks.
• Professional courage: respectfully challenge physicians, embrace difficult conversations, bring solutions, seek feedback, take accountability and ownership of your actions and results.
• Managing change: adapt to changing business needs, anticipate questions and challenges, deal with ambiguity, be open and transparent with your customers and your team, integrate into your customers’ practice.

WORKING CONDITIONS AND PHYSICAL DEMANDS

Must manage significant regional travel demands

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing document control professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Manager, Document Control at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Department Description:

Processes and controls documentation as required by GxP Regulations.

Position Summary:

Work with primary originators of documentation to ensure that documentation is written, edited, reviewed, and approved in a timely manner to meet established deadlines.

Core Responsibilities:

• Process Documents and associated historical data
• Ensure GxP documentation is correct, clear, and consistent.
• Finalize controlled documents in the Electronic Document Management System (eDMS) and maintain / distribute Official Copies.
• Contribute to / identify department improvement projects.
• Contribute to QADC document improvements and execute document updates through eDMS.
• Update and maintain workflows and various databases.
• Provide guidance to employees as needed.
• Ensure document formatting requirements are adhered to per departmental procedures.
• Perform data entry for tracking documents and departmental metrics.
• Develop and execute training to QADC and external departments on Document Systems.
• Prepare and manage data to be archived to off-site storage facility.
• Facilitate the Document Periodic Review Program.
• Maintain controlled documents in strict compliance to corporate policies and regulations.
• Facilitate the effective processing of Quality Systems documents to ensure they are maintained and archived in an organized and retrievable state for accountability and access for any regulatory body.
• Other duties as required.

Leadership qualifications include, among other requirements:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• High School Diploma or equivalent and 5+ years of related experience, or
• Associates degree or equivalent and 3+ years of related experience
• 2 years of GMP document control experience
• 1-2 years of MS Office Suite experience; MS Word - ability to create / modify templates, knowledgeable with styles formatting, and track changes functionality;
  MS Excel - ability to generate spreadsheets with applied knowledge of formula creation and maintenance, charting, and formatting
• Strong written and oral communication skills
• Time management skills
• Strong attention to detail

Preferred Qualifications:

• College degree or equivalent in related field
• Familiarity with working in a Document Management System (i.e. Veeva Vault QualityDocs, etc.)
• Technical writing experience

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Ability to lift and carry up to 15 lbs
• May require holiday coverage

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing sales professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Regional Sales Director at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

Joint Restoration Territory Manager is responsible for MACI sales and Surgeon growth.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Call on orthopedic surgeons and specialists in cartilage repair to deliver a targeted sales message based on accurate clinical information, using approved sales and marketing materials.
• Attend surgical implantation procedures, as needed, and provide education, training and support to clinical personnel and other staff associated with use and implant of Vericel Products.
• Ensure completion of Surgeon product training required by FDA.
• Work with customers to educate on product and procedure reimbursement across different insurance carriers and facilities and foster a relationship with case management team.
• Utilize corporate resources i.e. education speaker programs, lunch budgets, and local conference attendance.
• Knows, understands, and follows Vericel and Government regulations.
• Other projects and assignments as needed.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership qualifications include, among other requirements:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as a role model for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Bachelor’s Degree, with a science, business or marketing degree preferred.
• Non-Degree candidates must have 8 plus years of relevant surgical sales experience, orthopedics and particularly sports medicine preferred.
• 3+ years of proven successful sales results. OR sales and orthopedic background preferred.
• Knowledge of anatomy and physiology strongly desired in order to understand where and how products work clinically.
• Candidate will need to undergo and successfully pass hospital credentialing requirements in order to perform certain aspects of their job, including a 10 panel drug screen.
• Self-motivated, high commitment and dedication with proactive mindset.
• Detail oriented with strong analytical and problem-solving skills along with the ability to review voluminous amounts of information (e.g., data tables) and distill relevant information.
• Ability to develop and manage relationships to meet short, and long-term business objectives.
• Team player with the ability to lead and build consensus and to work on multiple projects simultaneously.
• Able to demonstrate flexibility, independence, initiative, creativity, confidentiality, integrity, stability and efficiency.
• Excellent verbal and written communication, strong presentation and training skills, and interpersonal and relationship building skills.
• Project management skills and proficiency with Microsoft applications.

WORKING CONDITIONS AND PHYSICAL DEMANDS

Travel minimum 90% of the time within territory. Ability to attend surgery and stand for long periods of time.

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing sales professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Regional Sales Director at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

Joint Restoration Territory Manager is responsible for MACI sales and Surgeon growth.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Call on orthopedic surgeons and specialists in cartilage repair to deliver a targeted sales message based on accurate clinical information, using approved sales and marketing materials.
• Attend surgical implantation procedures, as needed, and provide education, training and support to clinical personnel and other staff associated with use and implant of Vericel Products.
• Ensure completion of Surgeon product training required by FDA.
• Work with customers to educate on product and procedure reimbursement across different insurance carriers and facilities and foster a relationship with case management team.
• Utilize corporate resources i.e. education speaker programs, lunch budgets, and local conference attendance.
• Knows, understands, and follows Vericel and Government regulations.
• Other projects and assignments as needed.
• Location: Miami

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership qualifications include, among other requirements:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as a role model for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Bachelor’s Degree, with a science, business or marketing degree preferred.
• 2-5 years of proven successful sales results. OR sales and orthopedic background preferred.
• Knowledge of anatomy and physiology strongly desired in order to understand where and how products work clinically.
• Candidate will need to undergo and successfully pass hospital credentialing requirements in order to perform certain aspects of their job, including a 10 panel drug screen.
• Self-motivated, high commitment and dedication with proactive mindset.
• Detail oriented with strong analytical and problem-solving skills along with the ability to review voluminous amounts of information (e.g., data tables) and distill relevant information.
• Ability to develop and manage relationships to meet short, and long-term business objectives.
• Team player with the ability to lead and build consensus and to work on multiple projects simultaneously.
• Able to demonstrate flexibility, independence, initiative, creativity, confidentiality, integrity, stability and efficiency.
• Excellent verbal and written communication, strong presentation and training skills, and interpersonal and relationship building skills.
• Project management skills and proficiency with Microsoft applications.

WORKING CONDITIONS AND PHYSICAL DEMANDS

Travel minimum 90% of the time within territory. Ability to attend surgery and stand for long periods of time.

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing sales professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Regional Sales Director at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

Joint Restoration Territory Manager is responsible for MACI sales and Surgeon growth.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Call on orthopedic surgeons and specialists in cartilage repair to deliver a targeted sales message based on accurate clinical information, using approved sales and marketing materials.
• Attend surgical implantation procedures, as needed, and provide education, training and support to clinical personnel and other staff associated with use and implant of Vericel Products.
• Ensure completion of Surgeon product training required by FDA.
• Work with customers to educate on product and procedure reimbursement across different insurance carriers and facilities and foster a relationship with case management team.
• Utilize corporate resources i.e. education speaker programs, lunch budgets, and local conference attendance.
• Knows, understands, and follows Vericel and Government regulations.
• Other projects and assignments as needed.
• Location: West Palm Beach, FL

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership qualifications include, among other requirements:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as a role model for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Bachelor’s Degree, with a science, business or marketing degree preferred.
• 2-5 years of proven successful sales results. OR sales and orthopedic background preferred.
• Knowledge of anatomy and physiology strongly desired in order to understand where and how products work clinically.
• Candidate will need to undergo and successfully pass hospital credentialing requirements in order to perform certain aspects of their job, including a 10 panel drug screen.
• Self-motivated, high commitment and dedication with proactive mindset.
• Detail oriented with strong analytical and problem-solving skills along with the ability to review voluminous amounts of information (e.g., data tables) and distill relevant information.
• Ability to develop and manage relationships to meet short, and long-term business objectives.
• Team player with the ability to lead and build consensus and to work on multiple projects simultaneously.
• Able to demonstrate flexibility, independence, initiative, creativity, confidentiality, integrity, stability and efficiency.
• Excellent verbal and written communication, strong presentation and training skills, and interpersonal and relationship building skills.
• Project management skills and proficiency with Microsoft applications.

WORKING CONDITIONS AND PHYSICAL DEMANDS

Travel minimum 90% of the time within territory. Ability to attend surgery and stand for long periods of time.

POSITION SUMMARY

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality Assurance professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Senior Manager, Quality Operations at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

Under Manufacturing management guidance, the Manufacturing Team Lead I or II is responsible for oversight of manufacturing activities in the cleanroom for cell therapy products meeting internal and regulatory requirements.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Perform aseptic manufacturing procedures inside an ISO Class 7 cleanroom in accordance to established SOPs, cGMPs, and Safety regulations.
• Maintain frequent communication with Supervisor to exchange information, recommendations and to review daily cleanroom activities.
• Under Management guidance, provide consistent, ethical and responsible leadership to manufacturing teams to meet production demands.
• Provide guidance to staff consistent with cGMP and corporate quality governance.
• Serve as a liaison between employees and Management.
• Observe for process consistency within the team and report any observations to Management when problems occur. Receive guidance from Management regarding remediation.
• Serve as a technical resource for questions and/or investigate manufacturing issues.

Additional Responsibilities:

• Serve as a Qualified Trainer and assist with staff training.
• Assist Management with monitoring the staff and workload to meet or exceed productivity performance standards.
• Recommend ideas for improvement in work practices.
• Assist technicians with EBR issues and provide technical guidance.
• May provide input for the development of manufacturing policies (including operational, safety and quality programs).
• Perform tasks in Manufacturing software systems (e.g., sales order entries, confirming Preactor inventory and setting schedules including changes, GP entry and verification of process work, etc.).
• May learn the Preactor scheduling system and function as a backup Scheduler.
• May assist Management with coaching and mentoring of staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.
• Assist Management by offering feedback for annual performance reviews and provide ongoing input based on established goals.
• Perform activities within TeamShare (e.g., workflows, periodic reviews, etc.),
• Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as a role model for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Biotechnology Certificate with 2+ years of experience (Lead I) or 4+ years of experience (Lead II) working in a cGMP environment in the biotech or pharmaceutical industry.
• Must possess solid working knowledge of MS Office (Word/Excel/PowerPoint).

Preferred Qualifications:

• Bachelor’s Degree (Life Sciences or related field) or equivalent
• Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.
• Qualified as an On the Job Trainer.
• Excellent communication skills, written and verbal.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• May be required to sit for long periods of time while performing cell culture operations.
• Must be able to lift, carry, push and pull up to 50 lbs.
• Ability to work 1 weekend day.
• Rotating holiday coverage.
• Ability to gown and gain entry to manufacturing areas

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Marketing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Senior Product Manager at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

The MACI® Product Manager is primarily a downstream marketing role jointly responsible for MACI implant delivery techniques and instrumentation. Following approval by the FDA, the role will be highlighted by the commercial launch of the MACI Arthro™ surgical technique which utilizes custom designed instrumentation to facilitate this procedure. In addition to overall general planning, support, and execution of the MACI brand, this position will work collaboratively to develop and refine the following:

• Training and educational resources and programs for surgeons and the sales team.
• Instrumentation portfolio management programs that may lead to instrumentation improvements or new instrument development for both open and, when approved, arthroscopic, MACI techniques.
• New product introduction, promotion, and early adoption of the MACI Arthro procedure, when approved.

The position will serve as a critical interface with key customers and opinion leaders in the field of sports medicine as well as internal cross functional business partners in Sales, Medical Affairs, Life Cycle Management and other supportive business functions throughout Vericel. The role reports to the Senior Product Manager, Marketing.

ESSENTIAL FUNCTIONS

• Work collaboratively with cross functional teams to develop and refine surgical technique resources for both the MACI Sales Team as well as Orthopedic Surgeons
• Work with key customers, opinion leaders, consultants to optimize the utilization of existing instrumentation.
• Work with KOLs, Sales, Life Cycle Management and 3rd Party Vendors to refine and evolve all surgical instrumentation used in the MACI implant procedure.
• Support the brand management team in development and implementation of initiatives in conjunction and consultation with sales and training.
• Facilitate communication with cross-functional colleagues, including reporting on projects.
• Support the management of the marketing budget for the brand.
• Contribute to the brand strategy planning effort alongside sales team; including demand generation initiatives designed for health care providers and patients.
• Collaborate with brand team agency partners to develop promotional and educational resources and work closely with regional sales partners to understand changing market dynamics.
• Partner with key internal and external stakeholders to foster a collaborative, compliant and efficient MLR (medical, legal, regulatory) review and submission process.
• Facilitate the promotion and education of the brand during medical conference events; including identifying and maintaining strong relationships with customers and associations.
• Monitor market trends and competitive intelligence for distribution among the brand management team. Other projects and assignments as needed.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership qualifications include, among other requirements:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as a role model for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Bachelor’s Degree (Engineering, Marketing or Business Administration preferred)
• Minimum of 3-5 years in operating room (OR) sales and marketing experience in orthopedic surgery, including sports medicine surgery is highly preferred.
• Other experience with surgical product / instrumentation sales, marketing, and product development is also preferred.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Travel: 30% of time (and up to 50% at peak)
• Access to all hospital and surgery center operating rooms as needed to support brand strategies.
• Supporting surgical skills training courses as well as industry and professionally sponsored meetings, many of which occur over weekends.

POSITION SUMMARY

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing IT professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Senior Director, Information Systems at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

The Manufacturing Execution Systems (MES) Manager will drive efficiency and reliability in our manufacturing processes. This role involves developing MES support strategies, collaborating with vendors, optimizing system performance, and ensuring compliance with GxP regulations.

ESSENTIAL FUNCTIONS

• Develop and maintain a MES support strategy that integrates manufacturing process knowledge, equipment design, and quality standards with information technology to reduce downtime.
• Collaborate closely with the enterprise and external vendors to evaluate and implement MES application upgrades, hotfixes, and enhancements.
• Continuously monitor MES system performance, review logs, and diagnostic data, and respond appropriately to ensure optimal operation.
• Acquire a deep understanding of manufacturing processes and system configurations to provide well-informed recommendations for system optimization.
• Utilize strong technical writing skills to update SOPs, reference materials, and other controlled content.
• Provide on-call support for EBR/APS systems as needed to maintain uninterrupted operations.
• Mentor and train new MES resources, both internal and external, to foster a skilled and knowledgeable team.
• Manage software and configurations required for external system interfaces, facilitating seamless data exchange.
• Contribute to, facilitate, review, and update system development lifecycle and validation documents as needed for GxP IT implementation and enhancement projects.
• Support multiple ongoing IT initiatives within the MES environment, aligning technology solutions with business requirements.
• Evaluate business requirements and propose effective solutions, actively engaging with end users and stakeholders to plan and execute system enhancements and related changes.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

• Possess Pharmaceutical, Biotechnology, or Life Science industry experience.
• A Bachelor's degree in Computer Sciences, Information Technology, or Business Administration is required.
• Must have a 5-year proven track record performing in enterprise systems, including 5+ years of extensive MES solution deployment experience.
• Knowledge and experience with MES technologies.
• Experience leading and supporting enterprise large scale and other mission-critical applications like: Siemens MES.
• Siemens OpCenter Execution Pharma (EBR) and OpCenter APS (Scheduling) would be preferable.
• Database administration knowledge for Oracle, SQL and/or other platforms is preferable
• Knowledge of business intelligence platforms such as PowerBI and other data ETL and modeling tools is preferred
• Demonstrated leadership skills and experience working in diverse, multi-disciplined work groups.
• Knowledge of GMPs, GAMP 5, 21 CFR Part 11, Annex 11, MHRA/FDA Data Integrity.

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality Assurance professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Senior Manager, Quality Operations at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Department Description:

The Quality Assurance department ensures that the site operates at a high level of compliance and ensures quality decisions are being made in accordance with regulatory and site requirements.

Position Summary:

This position is responsible for operational support, including batch record review, media disposition, label issuance and reconciliation, archiving and final product packaging/release to the courier.

POSITION SUMMARY

Department Description:

The Quality Assurance department ensures that the site operates at a high level of compliance and ensures quality decisions are being made in accordance with regulatory and site requirements.

Position Summary:

This position is responsible for operational support, including batch record review, media disposition, label issuance and reconciliation, archiving and final product packaging/release to the courier.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership qualifications include, among other requirements:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as a role model for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Bachelor’s Degree in related field. Biotechnology certification will also be considered.

Preferred Qualifications:

• 1 year of GMP experience
• Strong written and verbal communication skills.
• Strong organization and time management skills.
• Proficient in MS Office suite.
• Experience in a biotech, pharmaceutical or other regulated industry.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Ability to lift and transport up to 30 lbs.
• Ability to work 1 weekend day.
• Rotating holiday coverage.

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality Control professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to a Senior Manager, Quality Control at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Department Description:

Quality Control (QC) is responsible for incoming inspection of components and raw materials, plus quality testing (e.g. analytical, microbiological) of intermediate, stability and final product samples to demonstrate that all products manufactured meet standards required for cGMP operations. Various techniques (e.g. assay transfers, validation and qualification of new instrumentation) are utilized within the Quality Control Laboratory to ensure cGMP compliance.

Position Summary:

Responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs for product release and validation.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Perform maintenance on complex laboratory equipment.
• Participate in training of less experienced staff.
• Participate in transfer methods from support groups to the QC laboratory.
• May perform finished product review and lot release.
• Perform cell culture maintenance and assays
• Coordinate departmental systems (i.e. inventory, documentation, equipment maintenance)
• Communicate inter-departmentally and with outside contacts to solve technical issues.
• Exercise sound judgment and decision making when problem solving.
• Revise standard operating procedures as needed.
• Perform deviation and lab investigations as needed.
• Master core responsibilities of an Analyst I.
• Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

Leadership qualifications include, among other requirements:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as a role model for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

• Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Bachelor's degree or equivalent and 2+ years of experience in a lab setting.
• 2+ years of experience with primary cells and cell culture
• 1 year of experience in flow cytometry and/or molecular biology

Preferred Qualifications:

• 1 year of experience in a cGMP lab environment.
• Proficient in Outlook, MS Word, Excel and lab based data management systems.
• Experience with microbiological testing, biological assays, or environmental monitoring.
• Experience in a biotech, pharmaceutical or other regulated industry.
• Excellent communication skills, verbal and non-verbal desired.
• Excellent technical writing and investigational skills.
• Experience with PCR based methodology or cell culture methods.
• Advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods, etc.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Ability to lift 40 lbs.
• Requires working both weekend days.
• Rotating holiday coverage.
• Rotating off-shift alarm coverage. Must carry a company issued cell phone.
• May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.

POSITION SUMMARY

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing quality systems professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Lead, Quality Systems at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

Department Description:

The Quality Systems (QS) Department manages Change Control, Design Control, Periodic Product Review, Inspection Readiness, Product Quality Reviews, Management Reviews and Risk Management. QS ensures compliance with company procedures and industry standards in support of cell therapy products.

Quality Systems Engineers are focused on the oversight of the Quality Systems that allow for efficient and compliant execution of operational projects. QS Engineers work closely with subject matter experts to facilitate the development and rapid adoption of value-added changes and processes, ensuring implementation in compliance with regulations, procedures and policies.

Position Summary:

The QS Engineer II will assist in ensuring that quality systems are in place and cGMP compliance is maintained. Work and decisions will be based on a collaborative culture with individuals throughout the facility.

ESSENTIAL FUNCTIONS

Essential Functions:

• Draft and revise procedures as required to ensure that documentation and operations meet established requirements of regulations, cGMPs, and internal SOPs and company policies.
• Apply and maintain quality standards and procedures for quality systems.
• Review executed cGMP documents and participate in or lead the implementation of systems, processing and storage of cGMP information.
• Monitor the status of assigned quality system(s), providing periodic reports and status updates on the overall performance of the quality system(s).
• Operate in an environment of strict timelines.

Key Functions may be in support of one or more of the following:

Change Control/Design Control

• Oversee and or support the process of change control approval from evaluation of an initial proposal, through approval, implementation, closure and effectiveness review.
• Provide QA oversight of change controls to ensure that they meet the requirements of industry standards and procedures, and are clearly written and appropriately justified. Provide QA approval of those changes at various points in the change life cycle, utilizing a quality management system electronic workflow.
• Apply and interpret industry standards and local procedures governing the change control process to proposed changes, consulting with QA management as appropriate. Work with project teams to determine the change control approach for projects.
• Verify the completeness and correctness of supporting documentation for changes, including items such as engineering studies, validation protocols, technical reports, engineering drawings and SOP changes.
• Monitor the status of open changes, providing periodic reports and status updates on the overall performance of the change control system.

Risk Management

• Assist with scheduling and driving activities of the risk management program with respect to scheduling meetings, developing quality documentation and data management.
• Help ensure that manufacturing sites comply with the requirements of the risk management program and complete assessments and reports in a timely manner according to regulations, procedures and policies.
• Participate in the risk assessment process as it relates to assisting with training of personnel, categorizing risk and assigning report numbers.
• Provide clear and concise reports of risk management activities/assignments throughout the site and provide key metrics that monitor compliance for the risk management program.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

• Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Required Education and Experience:

• Bachelor’s degree or equivalent with 2+ years of relevant Quality/Compliance experience in a cGMP biotech or pharmaceutical regulated industry.
• Experience performing work that consistently requires independent decision making and the exercise of independent judgment and discretion in a cGMP environment.
• Experience writing and reviewing technical cGMP documents.

Preferred Education and Experience:

• A strong understanding of Medical Device and Biologics FDA regulations.
• Strong working knowledge of Trackwise or other quality management systems.
• Proven Risk Management/FMEA experience/knowledge.
• Good project management skills and working knowledge of statistical techniques.
• Experience serving as a Subject Matter Expert (SME) in regulatory inspections.
• Experience presenting in a group setting in areas of subject matter expertise.
• Experience influencing colleagues and management in a cross-functional environment.
• Strong written and verbal communication.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Occasional overtime may be required for support of site inspections.

POSITION SUMMARY

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing quality systems professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Lead, Quality Systems at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

Department Description:

The Quality Systems (QS) Department manages Change Control, Design Control, Periodic Product Review, Inspection Readiness, Product Quality Reviews, Management Reviews and Risk Management. QS ensures compliance with company procedures and industry standards in support of cell therapy products.

Quality Systems Engineers are focused on the oversight of the Quality Systems that allow for efficient and compliant execution of operational projects. QS Engineers work closely with subject matter experts to facilitate the development and rapid adoption of value-added changes and processes, ensuring implementation in compliance with regulations, procedures and policies.

Position Summary:

The Senior QS Engineer will assist in ensuring that quality systems are in place and cGMP compliance is maintained. Work and decisions will be based on a collaborative culture with individuals throughout the facility.

ESSENTIAL FUNCTIONS

Essential Functions:

• Develop, draft and revise procedures as required to ensure that documentation and operation meet established requirements of regulations, cGMPs, and internal Sops and company policies.
• Develop, modify, apply, and maintain quality standard procedures for quality systems.
• Review executed cGMP documents and participate in or lead the implementation of systems for the acquisition, processing and storage of cGMP information.
• Monitor the status of assigned quality system(s), providing periodic reports and status updates on the overall performance of the quality system(s).

Key Functions may be in support of one or more of the following:

Change Control/Design Control

• Oversee the process of change/design control approval from evaluation of an initial proposal, through approval, implementation , closure and effectiveness review.
• Provide Quality oversight of change/design controls to ensure that they meet the requirements of Vericel standards and procedures, and are clearly written and appropriately justified. Provide QA approval of those changes at various points in the change life cycle, utilizing a TrackWise electronic workflow.
• Apply and interpret procedures governing the change control process to propose changes, consulting with Quality management as appropriate. Work with project teams to determine change control approach for projects.
• Verify the completeness and correctness of supporting documentation for change, including items such as engineering studies, validation protocols, technical reports, engineering drawings and SOP changes. May also serve as the Quality approver for supporting documentation.
• Monitor the status of open changes, providing periodic reports and status updates on the overall performance of the change control system.

Risk Management

• Assist with scheduling and driving activities of the risk management program with respect to scheduling meetings, developing quality documentation and data management.
• Help ensure that manufacturing sites comply with the requirements of the risk management program and complete assessments and reports in a timely manner according to regulations, procedures and policies.
• Participate in the risk assessment process as it relates to assisting with training of personnel. Categorizing risk and assigning report numbers.
• Provide clear and concise reports of risk management activities/assignments throughout the site and provide key metrics that monitor compliance for the risk management program.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Required Education and Experience:

• Bachelor’s degree or equivalent in Science or Engineering with 5 -9 years of relevant Quality/Compliance experience in a cGMP biotech or pharmaceutical regulated industry.
• Experience serving as a Subject Matter Expert (SME) in regulatory inspections.
• Experience performing work that consistently requires independent decision making and the exercise of independent judgment and discretion in a cGMP environment.
• Experience presenting in a group setting in areas of subject matter expertise.
• Experience writing and reviewing technical cGMP documents.
• Strong written and verbal communication.
• Experience influencing colleagues and management in a cross-functional environment.
• Experience operating in an environment of strict timelines.

Preferred Education and Experience:

• A strong understanding of Medical Device and Biologics FDA regulations.
• Strong working knowledge of Trackwise.
• Proven Risk Management/FMEA experience/knowledge.
• Good project management skills and working knowledge of statistical techniques.

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Sales professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the VP Burn Care National Sales at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

Lead a sales culture of performance through execution excellence specific to strategy, tactical plans and key initiatives.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Support an environment that best allows Account Managers (AM) to succeed, including focusing on the welfare of our stakeholders and the patients they serve.
• Meet or exceed sales goals and achieve results through teamwork and collaboration.
• Provide leadership in development of selling strategies.
• Create a high performing organization through recruiting, training, performance management, coaching and mentoring of team.
• Maximize time in the field with Account Managers to offer continuous and ongoing coaching and development.
• Partner with Account Managers and Burn Clinical Specialists to optimize management of all Epicel and Nexobrid cases; must have ability to manage a case independently.
• Build a network of customer and industry contacts for sales development and marketing partnership.
• Maintain current knowledge of market and competitive trends.
• Ensure compliance with policies and procedures.
• Collaborate and partner effectively with peer and support functions.
• Organize and execute meetings that yield shared insight and result in actionable next steps.
• Communicate effectively and positively influence the behavior of others.
• Trust the actions of team members and assume best of intentions with due diligence to verify results
• Work closely with Account Managers to plan territory coverage and develop customer targeting strategies. Effectively deploy strategies that maximize human and financial resources.
• Foster appropriate coordination between the AMs and the Burn Clinical Specialists (BSC)
• Additional responsibilities include: participate in cross-functional strategy sessions, identify market trends through data analysis, proactively work with sales training team to ensure deployment of training to staff, present at Regional and National Sales Meetings, and effectively manage administrative and financial responsibilities

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

Leadership qualifications include, among other requirements:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as a role model for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Bachelor’s degree in Business or Marketing (preferred)
• 10+ years of experience in sales in pharmaceutical, biotech or medical device industry.
• 5+ years of experience directly managing a sales team in a complex selling environment. Demonstrated career progression within sales, marketing or training. (preferred)
• Proven track record of consistently meeting or exceeding goals and/or other quantitative targets and qualitative measures.
• Proven ability to plan, forecast, and manage financial information.
• Demonstrated experience in creative problem solving, advising management on sales strategy, and motivating team to achieve concrete goals.
• Excellent verbal and written communication, strong presentation and training skills.
• Ability to create meaningful relationships with key opinion leaders.
• Customer focused approach with includes responding to customer and team with a sense of urgency and professional respect.
• Strong leader with effective coaching and teambuilding skills.
• Strong understanding of product, disease state and competition
• Strong knowledge of managed care and product reimbursement of specialty pharmacy/buy & bill.
• Superior and persuasive negotiation skills required with the fortitude to sell, compete and be a self-starter.
• Strong working knowledge of MS Outlook, Word, PowerPoint. Working knowledge of MS Excel including basic formulas and formatting.
• Valid state driver’s license.

Preferred Qualifications:

• Knowledge of anatomy and physiology strongly desired in order to understand where and how products work clinically (burn background preferred).
• Self-motivated, high commitment and dedication with proactive mindset.
• Detail oriented with strong analytical and problem-solving skills along with the ability to review voluminous amounts of information (e.g. data tables) to distill relevant information.
• Ability to develop and manage relationships in an effort to meet short and long-term business objectives.
• Team player with the ability to lead and build consensus and to work on multiple projects simultaneously.

WORKING CONDITIONS AND PHYSICAL DEMANDS

Extensive travel required. Responsible for a large geography. Travel would consist of time spent in field with sales force, attending business meetings, industry meetings and working with key customers.

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Regulatory professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Director, Regulatory Operations at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

The Senior Manager of Regulatory Operations (Reg Ops) is responsible for supporting key functions within the Regulatory Operations team and across the Vericel organization. This includes the planning, submission management, and submission of regulatory applications, reports, and other documents required for product approvals and maintaining a compliant US License Marketing Authorization requirement, for biologics and devices products. The Senior Manager plays a critical role in ensuring compliance with regulatory requirements and enabling successful product development and distribution activities, for process improvement, vendor management, functional excellence, compliance with regulatory guidelines, regulatory health authority interactions, team management, leadership, and document management systems (RIMS).

The Senior Manager champions process improvement and functional excellence initiatives within the Regulatory Operations team. This includes identifying opportunities for optimizing processes, systems, and tools to improve the speed and cost-effectiveness of regulatory operations while maintaining data integrity and quality. The Senior Manager may also lead or participate in cross-functional teams to implement process improvements and drive operational excellence. Ensuring compliance with relevant regulatory guidelines, including 21 CFR and FDA/ICH guidelines, throughout the regulatory operations processes. Participate in interactions with regulatory health authorities, staying up to date with changes in regulations and industry standards and ensuring that regulatory submissions and documents are in compliance with current requirements.

ESSENTIAL FUNCTIONS

• Lead the business process of overall selection, implementation, and requirements for regulatory information management (RIM) systems: This involves taking ownership of the RIM systems used by Regulatory Operations and driving the selection, implementation, and ongoing management of these systems. This includes developing short and long-term roadmaps for RIM systems to align with the evolving needs of Regulatory Operations.
• Provide business ownership and strategic direction for RIM systems: As a leader in Regulatory Operations, it is important to provide strategic direction for RIM systems and ensure that they align with the overall business objectives. This involves collaborating with cross-functional teams such as Clinical, BioStats, PV, and CMC to understand their needs and aligning RIM systems accordingly.
• Collaborate on technology initiatives and work in a global environment: Regulatory Operations often works in a global environment with colleagues from various functional teams. Collaborating on technology initiatives, such as implementing new systems or upgrades, requires effective leadership skills to drive the project and ensure successful implementation.
• Promote a culture of quality, operational excellence, and continuous improvement: Regulatory Operations plays a critical role in ensuring compliance with regulatory requirements. Promoting a culture of quality, operational excellence, and continuous improvement is essential to maintain compliance and support the growth of the company.
• Partner with vendors and/or IT business partners: Regulatory Operations often relies on technology solutions provided by vendors or IT business partners. Building effective partnerships with these stakeholders is important to stay updated on technology trends, assess their applicability to business needs, and ensure that the technology solutions are effectively integrated into Regulatory Operations processes.
• Define and implement standards and process efficiencies for submission publishing and change management: Submission publishing is a critical aspect of regulatory operations, and defining standards and process efficiencies for this function is essential to ensure timely and accurate submissions. Change management communications are also important to effectively communicate updates and changes to internal stakeholders. Implementing efficient processes and standards for these functions is essential for smooth operations in Regulatory Operations.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Education

• Bachelor’s Degree required.
• Advanced degree (or progress towards one) is desired but not preferred.

Experience

• 6+ year of Regulatory Operations or related roles required.
• 10+ years of Regulatory Operations or related roles preferred.
• Working knowledge of drug laws, regulations and guidelines is essential.

Qualifications

• A solid understanding of Regulatory Affairs/Operations and expertise in submission and project management.
• Excellent technical understanding and proven, hands-on experience in technologies such as SharePoint, eCTD Publishing Tools, Veeva Vault RIM, SmartSheetes, and off-the-shelf and plug-in software for Authoring Templates, DXC Toolbox that supports the global Regulatory business.
• Strong understanding of Microsoft Office Suite (Word, Excel, Power Point, MS Project)
• Highly collaborative team player that can communicate clearly to both technical and non-technical stakeholders to understand challenges and drive for win-win outcomes.
• Exceptional problem-solving skills and ability to formulate innovative solutions that demonstrate both strategic and tactical thinking.
• Demonstrated ability to organize, prioritize, and execute projects to completion.
• Excellent judgment and interpersonal skills, consensus and relationship building.

POSITION SUMMARY

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Payroll professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Supervisor, Accounting at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

The Senior Payroll and Accounts Payable Specialist reports to the Accounting Supervisor within the finance department and collaborate with internal colleagues, and external vendors to ensure the efficient and compliant processing of payroll and Accounts Payable.

This position requires a high degree of accuracy and attention to detail, organization, and effective collaboration across departments. This is an exciting opportunity to join an organization in a role where you can contribute immediately.

ESSENTIAL FUNCTIONS

Core Responsibilities:

Payroll

• Process bi-weekly payroll for exempt and non-exempt employees in multiple states
• Ensure compliance with payroll tax laws in various jurisdictions
• Update and review employee and payroll records in ADP system
• Handle new hires, terminations, and compensation changes in ADP
• Process commissions, bonuses, miscellaneous payments and employee deductions correctly
• Process/manage equity related transactions in stock administration software
• Prepare journal entries and account reconciliations for payroll related items
• Filing of applicable regulatory forms for matters related to payroll
• Conduct research on payroll-related issues and provide clear and concise responses
• Perform bi-weekly payroll reconciliation
• Generate, provide analysis, and maintain payroll-related reports
• Communicate with employees at all levels and departments regarding payroll/stock compensation matters
• Maintain proper documentation in payroll folders
• Assist finance team with year-end reports and W-2 forms as needed

Accounts Payable

• Process vendor invoices, ensuring accuracy and adherence to company policies and procedures
• Review and reconcile accounts payable transactions, statements, and balances
• Collaborate with internal departments to resolve invoice discrepancies and facilitate timely payment processing
• Prepare check packets, ACH and wire transfers in compliance with company policies and payment terms
• Identify and resolve AP issue’s and suggest appropriate corrective procedures
• Correspond with vendors and respond to inquiries in a timely manner
• Generate, provide analysis, and maintain accounts payable-related reports
• T&E Processing; expense report processing in adherence to the company’s policy, ensuring approvals and payout in a timely manner
• Manage the company’s credit card program in adherence to the company’s policy, which includes reviewing and approving new card applications, timely payment, and reconciliation
• Assist in month-end closing activities, including preparation of journal entries, accruals, and account reconciliations
• Ensure all work performed is SOX compliant
• Perform any other assigned duties

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

• Associate degree in accounting, Finance or business required
• 5+ years of payroll experience
• 3+ years of accounts payable experience
• Knowledge of payroll principles and best practices
• Knowledge of Federal, State & Local employment tax laws
• Experience with working under strict deadlines and delivering payrolls with a high degree of accuracy
• Intermediate Excel skills needed to perform majority of role functions
• Proficient with Microsoft Office
• Proficient with payroll software
• Strong problem solving and analytical skills
• Self-motivated
• Excellent organizational skills and the ability to manage multiple high-priorities in a fast-paced environment
• Clear and concise written and verbal communication skills
• Ability to work both independently and collaboratively with external and internal peers

Preferred Qualifications:

• Experience with ADP and Microsoft Dynamics Great Plains strongly preferred

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Market Access professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the SVP Commercial Operations at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

The Senior / Executive Director of Pricing, Market Access Operations and Strategy will be responsible for leading the Market Access function at Vericel, reporting directly to the Senior Vice President of Commercial Operations. In addition to functional leadership, the position has three major components. The first is to develop and implement pricing strategies for Vericel’s marketed US brands including MACI® (autologous cultured chondrocytes on porcine membrane), Epicel® (cultured epidermal autografts) and NexoBrid® (anacaulase-bcdb). The second is to continue to optimize performance of Vericel’s first-in-class patient support program, branded as MyCartilageCare®. This includes direction and oversight over case management services as well as a limited specialty pharmacy network. The final component of the role is to continue to refine and facilitate clinical and health economic strategies to ensure continued patient access to Vericel’s commercialized brands in addition to developing pricing and market access strategies for products being evaluated in portfolio development initiatives.

This individual will serve as a key leader on the Commercial Operations team and will interface with peers in sales, marketing, finance, legal, medical and regulatory affairs providing commercial guidance for all commercial and government payer, reimbursement and brand access related activities as well as guiding the corporation’s market access function as it transitions to its next stage of growth.

DUTIES AND RESPONSIBILITIES

Essential Functions:

• Lead the Pricing and Market Access team and function at Vericel.
• Responsible for all payer / market access related activities for Vericel’s brands including MACI, Epicel and NexoBrid.
• Oversee and direct Vericel’s patient support and case management services as well as a limited specialty pharmacy network.
• Develop pricing and market access strategies for upstream / business development initiatives.
• Develop and implement health economic strategies to support brand adoption and improve patient access to Vericel products.
• Recommend and implement coding initiatives to develop and obtain appropriate product and procedural codes.
• Collaborate on commercial payer contracting strategies with our specialty pharmacy partners; Provide guidance on facility contracting and key account management strategies.
• Monitor and engage CMS (Medicare/Medicaid) relating to payment proposals for Outpatient Prospective Payment Systems, Surgery Centers, Physician Fee Schedules, and Hospital Purchase Orders by obtaining coding, coverage, and reimbursement information.
• Provide trends and impact analysis on reimbursement and economic value.
• Work closely with the Commercial team to position pricing and access messages and tools to educate and train the field and provide accurate reimbursement information to our customers and patients.
• Oversee the development of reimbursement reference materials.
• Lead all access development activities (e.g. Managed Medicaid, Government, Commercial insurance) in close cooperation with cross-functional teams (Sales, Marketing, Medical, Regulatory, Finance, Legal, Compliance and Business Development) on new product and procedure development and evidence-based value propositions.
• Develop and maintain relationships with professional medical organizations/societies to manage healthcare policy and reimbursement issues.
• Other projects and assignments as needed.

Leadership Responsibilities:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics as well as other applicable Vericel policies.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

• Bachelor’s Degree (Advanced Degree in Science, Healthcare or Business Administration preferred).
• Seasoned professional with 5-10 years’ experience in market access / payer reimbursement in medical device, life sciences, bio-tech and / or pharmaceutical industries.
• Strong problem solving and critical thinking skills required.
• Business / Market Access consulting experience a plus.
• Minimum of 3-5 years’ experience in working with commercialized products.
• Minimum of 3-5 years of leadership / management experience.
• Strong understanding of medical reimbursement with specialty pharmacies (billing, coding, coverage, and payment) in the healthcare system to work to resolve contract and billing issues with providers.
• Experience with patient support / hub services organizations.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Must be able to be onsite at Cambridge, MA Corporate headquarters: Hybrid work environment - 2-days/week option to work-from-home.

• Occasional domestic business travel, tradeshows, sales meetings, educational programs and customer and partner meetings.

POSITION SUMMARY

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to a Manager, Cell Therapy Manufacturing at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

Department Description:

Manufacturing of cell therapy products.

Position Summary:

Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Perform manufacturing procedures inside an ISO Class 7 clean room in accordance to established SOPs, cGMPs, and safety regulations.
• Perform aseptic manipulations of cell culture lots and final product assemblies.
• Document production operations in corresponding batch records and log sheets according to cGMPs and established SOPs.
• Input data from production records to existing databases.
• General housekeeping of manufacturing controlled areas.
• Perform clean room equipment sanitization.
• Record equipment metrology readings to ensure the equipment operates within specifications.
• Interact with other departments such as Engineering, Facilities, Materials Management, QA, QC, R&D, Training, and Validation.
• Review completed production records for accuracy.
• Work independently under general supervision and direction.
• Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success.
• Practice safe work habits and adhere to Vericel’s safety procedures and guidelines.
• Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

• Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Biotechnology certificate or equivalent with 0-2 years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry, or 3+ years of cGMP experience with GED or equivalent.
• Excellent communication skills, written and verbal.
• Organizational and planning skills and the ability to cooperate with others in a team environment.
• Experience with Microsoft Office.

Preferred Qualifications:

• Experience working in an ISO 7 cleanroom environment.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• May be required to sit for long periods of time while performing cell culture operations.
• Must be able to lift, carry, push and pull up to 50 lbs.
• Ability to work 1 weekend day.
• Rotating holiday coverage.
• Ability to gown and gain entry to manufacturing areas.

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing operations professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the senior Vice President, Operations at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

The Vice President of Operational Excellence is responsible for developing and implementing a holistic Lean Transformation program to enhance safety culture, boost operational efficiency, identify and resolve quality issues, and maximize efficiency. This role also includes overseeing all Industrial Performance-related programs, projects, and processes. The candidate will work closely with the Leadership team to foster a culture of continuous improvement and ensure that the site possesses the necessary Lean tools and knowledge to effectively support industrial performance objectives.

DUTIES AND RESPONSIBILITIES

Essential Functions:

• Accountable to design, establish and execute a Lean Transformation program that results in improved Safety Culture, increased efficiency, and identification and resolution of quality events.
• Govern and oversight of all programs/projects/process related to improving Operations efforts/Organizational Design/Performance/Work Force Planning within operations.
• Responsible for oversight installation and implementation of Lean. Ensure focus on all Lean elements; understanding capabilities and gaps to drive efforts to constantly improve performance across the site.
• Provide program design expertise and guidance to ensure programs are properly constructed and include all applicable projects and work streams.
• Partner with Leadership team to maintain continuous improvement culture and program at the site. Ensure sufficient capability in Lean tools/knowledge to support Industrial performance objectives.
• Track broad company performance against operational goals and performance metrics.

Leadership Responsibilities:

• Leadership responsibilities include, among other requirements:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as a role model for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

• A minimum of 10 years prior operational management experience including line management of Managers and Directors.
• Prior industry experience leading cultural, operational and compliance transformations with quantifiable results required.
• Acting as a role model for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgement in performing our jobs.
• Proven ability to drive cultural change and encourage commitment to continuous improvement.
• Strong change management skills
• Ability to lead, engage, and influence employees at all organizational levels.
• Bachelor’s degree in business management, science or a related field or greater than 15 years of related experience.

Leaderships Qualifications:

• Effective collaboration with employees is essential to align the Lean Transformation program with the organization’s broader strategies. The ability to communicate, influence and work seamlessly with everyone is a must.
• The role requires the ability to drive cultural change and inspire a commitment to continuous improvement. Strong change management skills, including the capacity to lead, engage, and influence employees at all levels of the organization, are critical.
• The ideal candidate should have a proven track record of strategic leadership in operations, with the ability to set a clear vision and direction for a Transformation program. They should possess the capacity to align this vision with broader organizational goals.