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 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, direct sales position responsible for generating demand for Vericel products and services by fostering HCP interest in, education of, access to, and buy-in at targeted burn centers. Success measured by goal achievement in alignment with Vericel values.

ESSENTIAL FUNCTIONS

Core Responsibilities:

Direct sales calls to key decision makers at targeted burn centers, including surgeons and support personnel, to engage in the selling process:

• Connecting with stakeholders to the point of earning trusted advisor status
• Discovering the current state at targeted accounts specific to burn treatment, including pain points, blind spots, and opportunities for Epicel to bring value
• Aligning with the key stakeholders regarding their pain points, blind spots, and where Vericel would bring value, assertively and credibly managing objections and misconceptions
• Advancing the key stakeholders to action, including biopsies of appropriate patients and f/u usage of Epicel with patients for whom it makes sense.

Develop and manage complex accounts via:

• Identifying and connecting with key stakeholders & support staff (account mapping)
• Developing and executing key account strategic plans (account planning)
• Maintaining an appropriate and consistent presence within key accounts among key stakeholders
• Maintaining complete awareness of evolving patient population and advocating for appropriate Vericel patients.
• Staying aware of competitive activities and threats
• Setting accounts up for success with Vericel products by providing or arranging (via BCS) appropriate training and support

Foster access to and procurement of Vericel products:

• Determining procurement process at each targeted account
• Leveraging reimbursement and coding expertise to optimize Vericel product coverage
• Ensuring account approval for Vericel products to the highest levels in key accounts
• Presenting to VAC and P&T committees

Manage territory for optimal performance and effectiveness

• Establishing and execute routing that results in appropriate coverage levels according to target emphasis
• Maintaining up-to-date records of each account and stakeholders within via CRM tool
• Creating and executing territory business plans that prioritize efforts and resources appropriately
• Attending conferences where presence offers strategic territorial value
• Attending procedures in key accounts where presence will enhance selling position

Partner with Burn Clinical Specialist partner to optimize management of all Epicel cases

Develop product advocates for peer-to-peer impact

• Connecting BTS-CS with stakeholders to develop case studies, white papers, advocates for conferences & Vericel programs, etc.

Expertly leverage promotional materials to effectively tell the Vericel story in a manner that inspires action, including marketing, clinical, and operational information

Work in partnership with BTS-CS (Clinical Support) partner(s) to:

• Optimize Vericel presence in key accounts and select procedures
• Leverage their experience to secure introductions to key stakeholders at key accounts
• Leverage their expertise to help activate dormant and new accounts
• Advance progress in KOL development

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

• 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.
• 3 to 5+ years of experience of hospital-based specialty healthcare products sales, with a track record of meeting or exceeding sales goals.
• Experience with hospital operating room environments.
• Strong background in territory and complex account management with an assertive “hunter” approach
• Strong clinical and scientific acumen, particularly in burns or wound care.
• Understanding of medical reimbursement (billing, coding, coverage, and payment) in the healthcare system and ability to work to resolve billing issues with providers.
• Ability to thrive in a cross-functional team.
• Bachelor’s or Master’s degree. Experience with burns or burn nursing a significant plus.

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 travel demands, including occasional weekend days

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 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, direct sales position responsible for generating demand for Vericel products and services by fostering HCP interest in, education of, access to, and buy-in at targeted burn centers. Success measured by goal achievement in alignment with Vericel values.

ESSENTIAL FUNCTIONS

Core Responsibilities:

Direct sales calls to key decision makers at targeted burn centers, including surgeons and support personnel, to engage in the selling process:

• Connecting with stakeholders to the point of earning trusted advisor status
• Discovering the current state at targeted accounts specific to burn treatment, including pain points, blind spots, and opportunities for Epicel to bring value
• Aligning with the key stakeholders regarding their pain points, blind spots, and where Vericel would bring value, assertively and credibly managing objections and misconceptions
• Advancing the key stakeholders to action, including biopsies of appropriate patients and f/u usage of Epicel with patients for whom it makes sense.

Develop and manage complex accounts via:

• Identifying and connecting with key stakeholders & support staff (account mapping)
• Developing and executing key account strategic plans (account planning)
• Maintaining an appropriate and consistent presence within key accounts among key stakeholders
• Maintaining complete awareness of evolving patient population and advocating for appropriate Vericel patients.
• Staying aware of competitive activities and threats
• Setting accounts up for success with Vericel products by providing or arranging (via BCS) appropriate training and support

Foster access to and procurement of Vericel products:

• Determining procurement process at each targeted account
• Leveraging reimbursement and coding expertise to optimize Vericel product coverage
• Ensuring account approval for Vericel products to the highest levels in key accounts
• Presenting to VAC and P&T committees

Manage territory for optimal performance and effectiveness

• Establishing and execute routing that results in appropriate coverage levels according to target emphasis
• Maintaining up-to-date records of each account and stakeholders within via CRM tool
• Creating and executing territory business plans that prioritize efforts and resources appropriately
• Attending conferences where presence offers strategic territorial value
• Attending procedures in key accounts where presence will enhance selling position

Partner with Burn Clinical Specialist partner to optimize management of all Epicel cases

Develop product advocates for peer-to-peer impact

• Connecting BTS-CS with stakeholders to develop case studies, white papers, advocates for conferences & Vericel programs, etc.

Expertly leverage promotional materials to effectively tell the Vericel story in a manner that inspires action, including marketing, clinical, and operational information

Work in partnership with BTS-CS (Clinical Support) partner(s) to:

• Optimize Vericel presence in key accounts and select procedures
• Leverage their experience to secure introductions to key stakeholders at key accounts
• Leverage their expertise to help activate dormant and new accounts
• Advance progress in KOL development

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

• 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.
• 3 to 5+ years of experience of hospital-based specialty healthcare products sales, with a track record of meeting or exceeding sales goals.
• Experience with hospital operating room environments.
• Strong background in territory and complex account management with an assertive “hunter” approach
• Strong clinical and scientific acumen, particularly in burns or wound care.
• Understanding of medical reimbursement (billing, coding, coverage, and payment) in the healthcare system and ability to work to resolve billing issues with providers.
• Ability to thrive in a cross-functional team.
• Bachelor’s or Master’s degree. Experience with burns or burn nursing a significant plus.

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 travel demands, including occasional weekend days

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 Tech, Senior.
• Effectively write and investigate deviations in TrackWise.
• Able to train in the role of an On the Job Trainer and become a Qualified Trainer.
• Able to make culture decisions based on cell observations.
• Perform transactions in ERP system.
• In addition to being fully qualified in MACI or Epicel, cross train and qualify in at least one core competency 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 4+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry or 6+ years of cGMP experience with GED or equivalent.
• Bachelor’s or higher degree (Life Sciences or related field) or equivalent with 2+ 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.

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 Program Management 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 Sr. Vice President, Corporate Development & Strategy 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

• Lead program management for cross-functional teams including R&D, Regulatory Affairs, Supply Chain, Sales & Marketing and Finance from concept through commercialization.
• Drive milestone achievements and go/no-go decision making to progress projects through development stages.
• Represent the program status, scenarios, and trade-offs to senior management, as well as other internal and external stakeholders (alliance management).
• Support development of regulatory documents and government agency interactions.
• Competency in high-level strategic analysis and detail-oriented execution.
• Engage external stakeholders including KOLs and PIs.
• Accountable for integrated development plans.
• Develop program budgets and track spend vs budget.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Accountable for creation and maintenance of development plans for internal pipeline.
• Utilize program management best practices to identify variance between plan and actual results on regular basis.
• Ensure alignment of program scope and strategic business objectives and applicable ISO, GMP and FDA regulations.
• Ability to influence and reach alignment in a matrix organization.
• Ensure compliance with all company product development processes and industry standard best practices (e.g., Design Control).
• Participate and lead all key technical and design reviews and constructively challenge the team and the organization to rethink assumptions.
• Determine and negotiate resource assignments with functional managers and other business leaders and own the decision(s) related to resource assignments within the project.
• Designate roles, responsibilities, goals and deliverables to all core and extended team members.
• Contribute to the overall improvement of product development process effectiveness.
• Translate the business and technical strategy into action items.

Additional Responsibilities:

• Assist in evaluations, negotiations and contracting (e.g.,vendors, suppliers) where appropriate.
• Prioritize actions items in development (e.g., document review)
• Assist Marketing in assessing competitive threats.

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 is required, advanced degree (MBA or Masters or PhD in a life sciences scientific discipline) preferred.
• 10+ years of experience in program management ideally with both drug and medical device processes.
• Thorough understanding of the drug and device development and commercialization process and essential activities across all key functional areas.
• Significant experience working across functional groups especially clinical, regulatory, supply chain and marketing.
• Experience leading multi-disciplinary teams in the planning and execution of projects.
• Proficiency in Microsoft Project and SmartSheet.
• Excellent written and oral communication skills.
• Proactive and hands-on with a high level of self-motivation and drive.
• Ability to work independently.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Some travel may be required.
• Flexibility to accommodate teleconferences outside of regular working hours.

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 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.

Clinical Account Specialist 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 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

Department Description:

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Facilities Maintenance 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, Facilites Maintenance 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.

Facilities is responsible for the GMP preventive maintenance program, corrective repairs and building upkeep, construction, commissioning, and decommissioning of equipment, and supervising 3rd party contractors who perform maintenance, construction, and cleaning services.

ESSENTIAL FUNCTIONS

Core Responsibilities

• Perform preventive and corrective maintenance with strict accordance to SOPs.
• Complete detailed documentation of maintenance work and follow established procedures for GMP document completion, review, and filing / retention.
• Understand and interpret system documentation including blueprints, sketches, layouts, wiring diagrams, specifications, and operating manuals in performing maintenance and repair activities.
• Assist in the installation of new equipment and plant systems.
• Assist in decommissioning of equipment and systems.
• Participate in cleanroom, laboratory, and office construction projects by cleaning, sanitizing, performing construction work, supervising contractors, moving materials.
• Perform general facility upkeep including painting, carpentry, plumbing, and electrical work.
• Respond to urgent work requests regarding employee safety and / or spills.
• Complete routine building inspection for reliability, environmental, and health and safety factors.
• Supply information and technical data for procurement of equipment repair parts.
• Perform light material handling duties.
• 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:

• High School Diploma or equivalent.
• 2+ years of experience with facilities and maintenance.

Preferred Qualifications:

• Construction experience.
• Trade school certification.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Work day starts at 7:30 AM.
• 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.
• Ability to lift up to 50 lbs.
• Ability to work outside, including on the roof of the building.
• Overtime and off shift accessibility is required.
• Participation in the On Call rotation is required

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.

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 Medical Communications 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, Medical Affairs 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 Medical Communications Manager of Medical Affairs will be responsible for medical content development, medical review and approval, medical writing, literature surveillance and competitive intelligence, and Veeva MedComms Management.

ESSENTIAL FUNCTIONS

• Medical Content Development
• Collaborate with clinical and medical colleagues across all franchises to design and develop medical materials for use by medical colleagues (i.e. Medical Information Request (MIR) responses, SMRs, literature summaries, medical presentations)
• Medical Review and Approval
• Review and approve commercial and medical materials across franchises. Generate a weekly summary of reviewed materials and changes to be presented to the Medical Affairs Director
• Medical Writing
• Produce scientific publications for Medical Affairs across franchises
• Literature Surveillance and Competitive Intelligence
• Conduct comprehensive and in-depth weekly literature searches across multiple medical science databases and social media platforms for franchises, and work with the MSL Team to compile monthly/quarterly summaries of key publications and/or relevant trending clinical topics in social media.
• Veeva MedComms Management
• Identify the KOL development, educational objectives, and publication opportunities that exist based on analysis of metadata within the Veeva MedComms system
• Update and continually optimize the configuration of Veeva MedComms, as well as the data entry business processes to ensure maximum utility of the Veeva platform
• Assist with the Medical Affairs Education and Publication Brand Plan across franchises through the generation of quarterly dashboards and reports that analyze MSL Team field activities
• Provide support to cross-functional groups with ad-hoc analysis and/or presentations about key MSL Team field insights, regional trends, emerging technology, and KOL targets in order to support commercial business activities

QUALIFICATIONS AND EXPERIENCE

• Master of Science, PharmD
• 5+ years of relevant experience in the area of medical writing, data analytics, medical communications, and medical affairs
• Strong analytic, writing, communication, and presentation skills
• Demonstrated ability to effectively collaborate with internal colleagues and external partners

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 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, account management position with anticipated responsibilities that include supporting the launch and sales of NexoBrid®, a registration-stage biological orphan product designed for the debridement of severe thermal burns. Following NexoBrid’s approval, activities include but are not limited to, calling on targeted Burn Centers to develop HCP interest, utilization protocols and advocacy, providing product in servicing, education, and training as well as general account management, including the coordination of Vericel resources to achieve commercialization objectives. Position will eventually include responsibilities with respect to other Vericel branded products (Epicel) in the Burn Care space.

ESSENTIAL FUNCTIONS

Anticipated Core Responsibilities:

Direct sales calls to key decision makers at targeted burn centers, including burn center directors and support personnel, to engage in the sales process:

• Connecting with key stakeholders to the point of earning “trusted advisor status”
• Investigating current patient management practices at targeted accounts specific to the care of patients with severe burns to identify opportunities and specific areas where the appropriate use of NexoBrid may benefit patients
• Being capable of assertively and credibly managing product objections and misconceptions
• Advancing the key stakeholders to action, including their development of appropriate utilization and patient management protocols

Manage territory for optimal performance and effectiveness

• Creating and executing territory business plans that prioritize efforts and resources appropriately.
• Maintaining up-to-date records of each account and stakeholders within CRM tool
• Attending conferences where presence offers territorial value
• Attending procedures where NexoBrid is being used to provide education and guidance on appropriate product use including patient preparation, product application and post operative care
• Expertly leverage promotional materials to effectively tell the NexoBrid and Vericel story in a manner that inspires action
• Partner with Burn Clinical Specialist (BSC) colleagues to supplement educational and clinical support at key accounts in accordance with leaderships guidance

Develop and manage complex accounts via:

• Identifying and connecting with key stakeholders & support staff (account mapping)
• Maintaining complete awareness of evolving patient population and advocating for appropriate product utilization
• Maintaining awareness of competitive activities and threats
• Coordinating use of extended Vericel resources to optimize product utilization and patient care with all Vericel branded products.

Foster access to and procurement of Vericel products:

• Presenting to VAC and P&T committees when required
• Determining procurement process at each targeted account
• Ensuring product economics understanding for NexoBrid at the highest levels in key account

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

• 3 to 5+ years of relevant experience of hospital-based specialty healthcare surgical product sales, with a track record of meeting or exceeding sales goals.
• Experience with hospital operating room environments.
• Strong background in territory and complex account management with an assertive approach
• Strong clinical, scientific and business acumen, particularly in burns or wound care.
• Ability to thrive in a cross-functional team and work effectively in the “team” environment
• A professional approach that sees patient care as the highest priority, with a strong drive to connect our products and services with every on-label patient who will benefit.
• Understanding of medical reimbursement (billing, coding, coverage, and payment) in the healthcare system.
• Bachelor’s or Master’s degree in a health-science field, business, marketing or communications preferred. Experience with burns or burn nursing a significant plus.
• Ideal Location: Atlanta, GA

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, and leverage internal support
• 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 travel demands, including occasional weekend days

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 finance 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 of Finance and Investor Relations 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, Corporate Finance and FP&A reports directly the to the VP of Finance and Investor Relations. This position is responsible for leading the financial planning processes, monthly financial analysis and quarterly management reporting. In addition, the Senior Manager will be the primary business partner for key leaders within the organization.

This is a highly visible role and in addition to supporting core FP&A activities, the Senior Manager will assist with investor relations and partner with the CEO/CFO and other leaders on strategic projects, including evaluating potential business development and other potential strategic transactions..

ESSENTIAL FUNCTIONS

• Manage and continually improve annual budgeting and quarterly forecasting process
• Own the annual budgeting process
• Complete quarterly or adhoc forecasts as needed
• Lead monthly financial analysis monthly / quarterly reporting
• Conducting monthly variance analysis vs. budget, forecast and prior year to gain insights into business performance vs. expectations
• Prepare and present monthly financial results to CFO and accounting leadership
• Update and continually improve quarterly board of director reporting package
• Maintain long term financial model for the company and analyze how investments/changes/strategic scenarios could impact multi-year P&L and value creation
• Maintain current year and multi-year corporate model for company
• Valuation analysis of existing business and potential strategic transactions using multiple valuation techniques and comparison of company to peers on multiple key metrics
• Work closely with VP of Finance as well as CFO and CEO to analyze and provide financial support for potential business development transactions
• Work closely with Business Development team to develop assumptions and create financial models for potential business development opportunities
• Ensure we are supporting brands/functions/company to ensure we are optimally investing to achieve highest growth while maintaining strong profitability profile
• Partner with brand teams to drive ROI/other metrics; provide financial support for marketing plans/resource decisions, ensure plans are supporting assumptions in Budget and Long-Range Plan/multi-year views
• Prepare key monthly financial reports for ELT members and Functions, including analyses of current performance
• Work with VP of Finance to be a key contributor to Investor Relations activities
• Help with preparation of quarterly earnings materials
• Analyze stock performance and trading trends vs. other comparable companies
• Review analyst reports and maintain consensus details
• Work closely with CEO & CFO with projects as required and support key corporate events and meetings

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 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:

• Minimum 8 years of experience in a similar role
• Advanced excel modeling skills
• Demonstrated ability modeling full financial statements (P&L, Balance Sheet, Cash Flow)
• Experience with corporate finance, valuation and financial modeling techniques
• General understanding of capital markets
• Strategic mindset
• Willingness to be into the details
• Strong written (Word & PowerPoint) and verbal communication skills
• Commercial and/or R&D finance experience preferred but not required
• Experience in banking, consulting and/or life sciences preferred
• MBA preferred

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

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.

The Quality Operations Supervisor leads a team of QA Specialists. The individual is responsible for the oversight as well as participation in the day-to-day Quality Operations activities which includes the disposition of in-process materials and final product packaging and release. The individual must be able to gown into classified manufacturing ISO 7 clean room areas, to conduct inspection of final product.

This position is also responsible for the being a quality reviewer for deviations, events and CAPAs. This includes providing metrics and adherence to timelines. The individual will be required to maintain a positive relationship and to effectively communicate with other departments to meet company goals.

ESSENTIAL FUNCTIONS

Staff Management:

• Develop and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
• Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
• Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.
• Develop work plans, assign tasks, and supervise team(s).
• Ensure staff has appropriate knowledge of department processes and procedures.

• Reconcile and approve time detail for employees in ADP and conduct regular 1:1s.
• Hold monthly staff meetings.

Department Management:

• Establish and report applicable department or organizational metrics which drive accountability.
• Accountable for project completions and achievement of compliance goals.
• Represent department in project team meetings.
• Interact with project teams and cross-functional groups.
• Address and/or escalate site compliance problems and issues.
• Lead and facilitate meetings/workshops.

Additional Responsibilities:

• Perform, as well as ensure that the review of batch records and release of intermediates is performed within required timeframes outlined in SOPs.
• Ensure operations documentation meets established requirements for cGMPs, internal SOPs, and company policies.
• Conduct review of testing results in support of release of intermediates and final product.
• Assist in deviation/nonconformance identification and resolution.
• Participate and/or help lead root cause analysis to investigate deviations to determine appropriate root cause and CAPAs and may be responsible for CAPA resolution.
• Initiate, lead, and act as SME for change controls.
• Able to independently make decisions on intermediate issues and escalating major issues to Senior Management,
• Perform validation protocol or final report review to ensure validation criteria and results are appropriate and comply with regulations and current industry standards.
• Interpret complex, explicit documentation to ensure quality standards and compliance are met.
• Provide training to new employees.
• Review and approve deviations, in support of product release.
• Ensure completion of organizational projects and goals.
• Represent organization on specific projects.
• Participate in the internal audit program, as necessary.
• Other duties as assigned.

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 or equivalent in related field or the equivalent combination of education and/or experience.
• 5+ years or more of increasingly complex quality assurance or manufacturing experience in the Biotech / Pharmaceutical industry.
• Strong interpersonal skills and ability to work in a team environment.
• Strong written and verbal communication.
• Strong organization and time management
• Proficient in MS Word, Excel, PowerPoint
• Through knowledge of cGMP regulations
• Experience directly managing employees

Preferred Qualifications:

• Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, validation, and process development.
• Knowledge of electronic batch records, ERP systems, and Quality Management Systems (TrackWise and Veeva).
• Ability to interpret Quality standards for implementation and review.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Ability to lift up to 30 lbs.
• Ability to work one weekend day.
• Rotating holiday coverage.
• Ability to gown and gain entry to the manufacturing areas.

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.

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 Validation 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 of Validation 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 Validation department performs equipment, utility, cleaning, sterilization, software, and process validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for cell therapies products. The department also functions as the liaison with the Metrology department and performs all equipment ownership and quality assurance review responsibilities associated with site calibration activities.

Position Summary:

Responsible for performing validation projects in a GMP biotech manufacturing facility.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Master core responsibilities of an Engineer, Validation, I.
• Develop and publish new validation project plans and protocols, execute protocols and write final reports with little to no supervision.
• Participate in equipment failure investigations, corrective/preventive actions and equipment release. Provide final approval for equipment release.
• Provide technical assistance to less experienced technicians/specialists.
• Routine and effective communication with immediate supervisor and other personnel within the group in addition to outside the department.
• Review and approve validation and calibration documentation.
• 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:

• Bachelor's Degree or equivalent and 4+ years of validation experience.
• Master’s Degree or equivalent and 2+ years of validation experience.
• 3+ years of experienced with process, equipment, utility, and/or software validation in a GMP regulated environment.

Preferred Qualifications:

• Proficient with GE Kaye Validator and/or ValProbe data acquisition systems.
• Working knowledge of GMPs.
• Excellent technical writing and verbal communication skills.
• Basic math and statistical skills.
• Must be people oriented and a team player.
• Experience with Microsoft Office including Excel, PowerPoint, Word, Project and Visio.
• Familiarity with temperature chamber, sterilization, cleaning, software and depyrogenation qualifications.
• Prior experience with troubleshooting, investigating and effectively documenting deviations and discrepancies on project execution.
• Experience with writing validation protocols, project plans and final reports and managing validation projects.
• Ability to read/interpret engineering drawings and design documents.
• Knowledge of risk management tools and techniques.
• Knowledge of international regulatory requirements.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• 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.
• May be required to lift, push or pull up to 40 lbs.