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Assistant Controller and Director of Accounting Finance and Accounting Cambridge 05/26/2021

Assistant Controller and Director of Accounting

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Finance and Accounting professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet.  Reporting directly into the Vice President & Corporate Controller at Vericel, this individual will also have direct exposure to the CFO, as part of the Finance leadership team at Vericel.  This is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a strong institutional shareholder base.

The Assistant Controller will be responsible for leading several aspects of the Accounting and Control processes across the business.  This individual will work closely with the Vice President & Corporate Controller to  oversee month end close processes, quarterly financial filings, and control processes and procedures.  The Assistant Controller and Director of Accounting will have direct responsibility for overseeing all aspects of General Ledger and Accounts Payable, Payroll, Fixed Asset, Prepaid, Leasing and Stock compensation accounting.   In addition, the Director of Accounting will work closely with the Associate Director of Financial Reporting to support Revenue accounting.  Will also partner with FP&A leadership to track financial performance versus budget and forecasts.  This position will have 3 direct reports.

In this highly visible role, the Assistant Controller will work cross-functionally with leaders across the company to support, maintain and enhance accounting and close processes while also supporting annual and multi-year corporate planning processes and monthly and quarterly P&L performance tracking.  Additionally, the Assistant Controller will partner with senior leadership on other strategic projects, including evaluating potential business development and other potential strategic and financing transactions.

 

Key Responsibilities:

  • Oversee monthly and quarterly financial close processes and lead all general ledger and operating expense oversight
    • Ensure all expenses and activities are in compliance with US GAAP
    • Directly oversee all general ledger entries with timely and accurate reporting and all related month-end close activities
    • Manage the accounts payable department and department accrual process during month-end in addition to annual 1099 reporting
    • Oversee prepaid expenses, lease expenses and fixed assets
    • Oversee accounting for stock compensation expense including direct management with the Company’s third-party stock administrators and transfer agent, SEC Form 3/4/5 filings and management of the ESPP program
    • Assist with monthly state tax accounting and related requirements by working directly with outside tax consulting firm in addition to ad hoc tax projects (R&D tax study, etc)
    • Partner with Human Resources to manage annual benefit plan audit and IRS audits
    • Review payroll and gain a deep understanding of the payroll structure specific to Vericel’s Massachusetts based manufacturing staff.
    • Oversight of 401k accounting and other related pay rules
    • Oversee the Company’s expense reporting process
    • Manage the financial reporting of the annual Proxy
    • Work closely with internal legal department to ensure adherence to trading policies and procedures
    • Assist with treasury management including maintaining working relationship with investment manager, reviewing related monthly and quarterly accounting requirements and reviewing all cash accounting
    • Lead preparation and oversight of technical accounting memos
    • Partner with Technical Accounting and FP&A leadership on analyses of current performance
  • Ensure all proper controls processes are in place and work with external auditors to ensure all requirements are met
    • Provide support to the external accounting firm on quarterly and annual review and audit requests
    • Ensure internal control compliance (SOX) and work closely with internal and external auditors on documentation and functionality of controls
    • Enhance the Company’s policies and procedures related to multiple accounting areas
  • Manage a team of accounting professionals
    • Manage a team of three accounting professionals
    • Provide mentorship and training to the team
    • Ensure robust development plans in place for team members
  • This position can be based in Vericel's Cambridge, MA or Ann Arbor, MI office 

 

Key Skills Required for Position:

  • 10+ years of experience; CPA required
  • Bachelor’s degree in accounting required; master’s degree in accounting preferred
  • Big 4 accounting firm experience required
  • 5+ years Public company experience (which can include combination of public clients and public company experience in industry)
  • Life sciences/Biotech/Medtech experience strongly preferred
  • Expertise and experience in US GAAP accounting and SOX
  • Experience with Excel, Powerpoint and Word
  • Strategic mindset with ability to manage multiple deliverables and projects
  • Willingness to be into the details
  • Strong written and verbal communication skills

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Buyer/Planner II Material Management Cambridge 06/09/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Buyer/Planner professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Senior Manager, Supply Chain at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Department Description:

The Materials (Supply Chain) Department and Buyer/Planner II are responsible for ensuring an uninterrupted supply of materials essential for the functioning of assigned product lines and areas.

ESSENTIAL FUNCTION

  • Review purchase requisitions to ensure that they meet the organization's compliance.
  • Create Purchase Orders; maintain accurate open PO lines to define inbound quantities and due dates from suppliers.
  • Managed returned goods to suppliers.
  • Confirm that modifications and changes to existing orders are properly documented and processed.
  • Track status of back orders and inventory aging report.
  • Partner with internal customers when needed to expedite purchase requisitions or identify .solutions for supply chain disruptions which may include the sourcing of alternative providers
  • Resolve pricing and/or invoicing discrepancies with suppliers.
  • Plans the replenishment of materials to support the production schedule, while controlling inventory turns and materials shortages.
  • Conducts material planning and inventory management for assigned raw materials.
  • Maintains accurate data regarding Bill of Materials associated with all raw materials.
  • Act as liaison with suppliers and Vericel finance during annual standard cost updates.
  • Requests quotes from suppliers, performs new supplier sourcing and evaluation.
  • Adheres to appropriate Standard Operating Procedures for business planning unit to ensure compliance with SOPs, ISO 9000, and cGMP procedures, MRB, Sarbanes-Oxley Controls, and corrective action goals.
  • Properly escalate any known supply chain disruptions, order discrepancies or contract matters for internal review and remediation.
  • Create, prepare, and maintain reporting to provide data to monitor trends and allow site business decisions on a timely basis.
  • Other job duties are required.

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.

Basic Qualifications:

  • B.S. degree (or equivalent experience) and 2+ years of work experience.
  • A.A./A.S and 4+ years of relevant experience.
  • GED, High school diploma or equivalent with and 6+ years of relevant experience.
  • Experience working on cross functional teams.
  • Strong written and verbal communication skills.
  • Proficiency in all Microsoft Office Applications.
  • Familiar with Purchasing and Quality Systems.

Preferred Qualifications:

  • Experience in Life Sciences.
  • Familiar with cGMP processes.
  • Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.

 

 

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Clinical Account Specialist - Baltimore, MD Commercial Baltimore, MD - Homebased 05/27/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Clinical Account Specialist looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Regional Sales Director, MACI at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

ESSENTIAL FUNCTIONS

  • 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.
  • Territory Borders include Baltimore, Annapolis, the Eastern Shore of Maryland, Prince Georges, Charles and Calvert county
  • Other projects and assignments as needed.

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 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, with a science, business or marketing degree preferred.
  • 3-5 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.
  • Ideal candidate will live in Baltimore County, Anne Arundel county, Prince Georges county, or Howard County

WORKING CONDITIONS AND PHYSICAL DEMANDS

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

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Executive Assistant General and Administrative Cambridge 03/12/2021

POSITION SUMMARY

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Executive Assistant professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the CEO at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

The Executive Assistant will report to the Chief Executive Officer and provide high-level administrative support to the Executive Leadership Team. The Executive Assistant will serve as the primary point of contact for internal and external parties on all matters pertaining to Corporate Affairs, and will coordinate Board meetings, serving as a primary resource for the Board. This person will serve as a liaison to the executive team and senior management teams. Will organize and coordinate initiatives for the executive team.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Provide administrative support to the Executive Leadership Team and the Chief Executive Officer using a high level of discretion and confidentiality.
  • Coordinate Board meetings, serving as a primary resource for the Board.
  • Analyze needs and problems, and determine approach and priority in collaboration with senior leaders, their teams and administrative colleagues across functions
  • Prioritize conflicting needs, handling matters expeditiously and proactively. Follow through on projects to successful completion, often with tight timelines.
  • Collect and prepare information for use in executive discussions and meetings.
  • Contact company employees at all organizational levels to gather information and/or prepare reports.
  • Interact internally and/or externally with senior individuals or officers regarding information that may be sensitive or confidential in nature.
  • Coordinate calendars, schedules, meetings, training and travel arrangements for Executive Leadership Team.
  • Prepare expense reports for executive(s) and Board of Director members; manage corporate credit card usage and reconcile charges and submit to Finance.
  • Coordinate and initiate conference calls, Microsoft Teams meetings, and manage all meeting details such as room reservations, preparing agendas, securing necessary IT equipment, catering, and attendee updates.
  • Prepare and distribute presentation materials for internal and external meetings, including board meetings.
  • Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Organize and prioritize information, correspondence and calls for the Executive Leadership Team; draft written responses or reply by phone or e-mail when necessary.
  • Respond to regularly occurring requests for information.
  • Organize and maintain files and records.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leaderships 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 strongly preferred, or equivalent combination of education and experience may be accepted
  • 10+ years of administrative experience with 5+ years of experience supporting executive level is required
  • Extensive Microsoft Office skills are required, as well as Internet research abilities.
  • Experience with heavy calendar management and national travel scheduling and booking.
  • Strong written and verbal communication skills.
  • Excellent customer service skills required.
  • Project coordination experience and the ability to work well with all levels of internal management and staff, outside clients and vendors required.
  • Ability to exercise sound judgment and confidentiality required.
  • Excellent organizational skills and attention to detail essential.
  • Exercise a high degree of professionalism, diplomacy and discretion in handling confidential information.
  • Ability to work independently and collaboratively with the Executive Leadership Team.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Lead, Manufacturing Manufacturing Cambridge 05/17/2021

POSITION SUMMARY

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Lead, Manufacturing professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Manager, MACI Manufacturing at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with 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:

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:

  • 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
 

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Manufacturing Technician Manufacturing Cambridge 06/01/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Manufacturing professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Senior Manager, Manufacturing at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with 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.

 

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.

 

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 clean room 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.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Production Scheduler Manufacturing Cambridge 05/07/2021

POSITION SUMMARY

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Production Scheduler professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Manager, MACI Manufacturing at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with 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 creation and maintenance of the master manufacturing production work schedule which includes the manufacture of commercial cell therapy products.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Create, confirm and maintain manufacturing production schedule for multiple product lines using the Preactor scheduling software program.
  • Assess customer orders, available staff, equipment and cellular inventory to effectively set and simultaneously manage production schedules for multiple product lines.
  • Plan daily, weekly and monthly manufacturing schedules and the associated resource allocation.
  • Constantly monitor, assess and when necessary provide recommendations to improve the effectiveness and functionality of the scheduling software (e.g., beneficial reports, updates for new activities, etc.).
  • Support and participate in scheduling related projects and key initiatives that directly support the Manufacturing department, including resource planning of labor, materials and equipment.
  • Perform sales order support using the ERP, scheduling and CRM systems.
  • May provide support for inventory management and control within ERP and MES systems.
  • Serve as a liaison between Manufacturing and Customer Care.
  • Other duties as assigned.

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 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 or higher degree and 4+ years of experience with manufacturing operations scheduling.
  • Associate degree and 6+ years of experience with manufacturing operations scheduling, or 8+ years of scheduling experience with GED or equivalent.
  • Excellent communication skills, written and verbal.
  • Advanced to expert level ability with Microsoft office.
  • Experience with ERP, MES, CRM and scheduling systems (e.g., Microsoft Dynamics GP, MFG/Pro, SAP, Preactor, etc.).

Preferred Qualifications:

  • Experience in cGMP production environments.
  • Experience working within a regulated environment that is frequently audited by internal and external Agencies, such as the FDA and ISO.
  • Proven analytical, problem solving and facilitation skills

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • May be required to sit for long periods of time while performing physical duties.
  • May be required to provide weekend coverage.
  • Monday - Friday schedule 12:30pm-9:00pm
  • Rotating holiday coverage.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
QC Analyst I Quality Control Cambridge 06/03/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Quality Control professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Senior Manager, QC Microbiology at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with 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:

Perform routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Perform microbiological assays for in-process and final product samples.
  • Perform analytical methods for final bulk material/finished goods.
  • Test and disposition of raw materials and perform environmental monitoring.
  • Review of QC data for compliance to procedures and specifications.
  • Calculate and evaluate results.
  • Participate in lab maintenance and administration duties.
  • Initiate lab investigations and deviations.
  • Lab support including but not limited to glass washing, autoclaving, etc.
  • Effectively demonstrate an understanding of CGMPs and how it applies to specific responsibilities.
  • Follow accurate oral and written procedures for testing of in-process and final product samples.
  • Provide input to the technical composition of operating documentation.
  • Work independently under general supervision and direction.
  • Work in compliance with cGMPs.
  • Practice safe work habits and adheres to Vericel’s safety procedures and guidelines.
  • Maintain lab documentation and notebooks, ensuring timely review, reconciliation and filing.
  • Other duties as assigned.

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.

Basic Qualifications:

  • Bachelor’s degree or equivalent education and experience.

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 or environmental monitoring.
  • Experience in a biotech, pharmaceutical or other regulated industry.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Ability to lift 40 lbs.
  • Requires working one day per weekend.
  • 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.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
QC Analyst II Quality Control Cambridge 06/03/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Quality Control professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Manager, QC Lot Release at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with 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.
  • 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:

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.

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 one day per weekend.
  • 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.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Quality Assurance Specialist II Quality Assurance Cambridge 06/03/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Quality Assurance professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Manager, Quality Operations at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with 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, final product packaging/release to the courier, customer complaint audits, write and/or revise standard operating procedures

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Master core responsibilities of Specialist I.
  • Maintaining and adhering to compliance requirements for established quality systems programs.
  • Identify issues, provide recommendations as well as executing compliance improvements.
  • Participate in mid-scale projects or assignments.
  • Address and/or escalate compliance problems and issues.
  • Interact with project teams and applicable research groups as they impact the quality operation.
  • Product complaints: independently receive, review, audit accompanying patient file, and send to Customer Care.
  • Independently initiate QA deviations and perform investigations, including determining root cause and planning corrective actions.
  • Support the training of specialist I’s.
  • Other duties as assigned.

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.

Basic Qualifications:

  • High School Diploma plus 3+ years of related experience in Quality Assurance.
  • Basic knowledge of GMP regulations

Preferred Qualifications:

  • Strong written and verbal communication skills
  • Strong organization and time management skills
  • Experience with Electronic Quality Management Systems (Trackwise)
  • Proficient in MS Word, Excel, and PowerPoint

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Able to lift and transport up to 40 lbs
  • Must work 1 weekend day (Schedule: Tuesday-Saturday)
  • Rotating holiday coverage.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Quality Control Analyst, Senior Quality Control Cambridge 06/03/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Quality Control professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Senior Manager, QC Microbiology at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with 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 QC testing in a cGMP lab for raw material release, final product/in process testing and process qualifications
  • Conduct data analysis of testing results, and review data obtained for compliance to SOP and specification.
  • May transfer methodology from other groups and may maintain complex equipment.
  • Author reports, SOPs and other documentation for quality testing.
  • Provide training and technical leadership to less experienced staff.
  • Participate in and/or perform laboratory investigations and non-conformance deviations.
  • Perform finished product review and lot release.
  • Manage departmental projects.
  • Serve as the laboratory point of contact for less experienced staff when management is not present (weekends, holidays)
  • Participate in the execution of corrective and preventative action plans as well as the initiation and follow through for change controls.
  • Author protocols and technical reports related to the implementation of QC equipment.
  • Master core responsibilities of an Analyst II.
  • Other duties as assigned.

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 the company 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 4 +years of experience in a lab setting.

Preferred Qualifications:

  • Experience as a technical leader in a strong team environment and work independently to successfully balance short and long term project objectives.
  • Experience with Deviation Management and Change Control.
  • Experience with complex analytical methods such as PCR based methodology or cell culture methods.
  • Experience with assay/equipment validations/transfers.
  • Experience with microbiological testing or environmental monitoring.
  • Excellent communication skills, verbal and non-verbal desired.
  • Excellent technical writing and investigational skills.
  • Advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods, etc.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Ability to lift 40 lbs.
  • Requires working one day per weekend.
  • Rotating holiday coverage.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Scientist II Research and Development Cambridge 06/03/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing R&D Scientist professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director of R&D at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

Department Description:

The Research and Development group within Vericel supports the continuing development, characterization and validation of manufacturing methods, novel assays, new technology and operational improvements. This group manages technology transfers, clinical manufacturing, training, database development, trending analysis and stability. The R&D team plays an important role in commercial manufacturing troubleshooting, root cause investigation, process optimization and product life cycle management.

Position Summary:

Applies scientific and/or engineering principles and expertise in the design and development of robust, cost-effective manufacturing procedures and associated analytical method that meet quality, GMP, regulatory and health, safety, and environmental standards.

Core Responsibilities:

  • Demonstrates a comprehensive solid understanding and use of scientific / engineering principles and professional practices, to solve a wide range of complex problems in creative and practical ways.
  • Leads design reviews, cross-functional development teams and provides scientific / engineering support and guidance in the development, scale-up, optimization and operation of methods for the production and testing of new components, technologies and products.
  • Maintains and demonstrates significant knowledge of state-of-the art principles and theories in area of responsibility.
  • Independently reviews existing process and analytical development and production data; designs and conducts necessary experiments; interprets results; recommends changes or additional experiments.
  • Designs, executes, and interprets experiments to identify new methods to enhance the manufacture of or characterization of products in regard to safety, identity, strength, purity, stability and quality with minimal direction.
  • Stay abreast of new developments/technologies in areas of responsibility. Prepares proposals for introduction of technologies outlining the positive impact to the product for cost and/or quality.
  • Participate in establishing project strategy in consultation with management.
  • Represents the corporation in the greater biotech community by publishing in peer review journals and participation in scientific / technical conferences.
  • Represents the organization as the prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.
  • Guides the successful completion of major programs and may function in a project leadership role.
  • Directs the work of more junior staff. Provides technical guidance and trains less experienced staff.
  • Other duties as assigned.

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:

  • BS and 9+ years of related work experience, or
  • MS and 7+ years of related work experience, or
  • Ph.D. or equivalent in Biology, Biochemistry, Biomedical, Chemical, or Mechanical Engineering, or related fields and 4+ years of related work experience.
  • Expertise in one or more of the following: Bioengineering, Molecular Biology, Flow Cytometry.
  • Advanced expertise in mammalian cell culture and related techniques.
  • Proficient with technical writing and statistical analysis to produce technical and/or validation protocols and reports.

Preferred Qualifications:

  • 4+ years of experience working on development or support of assays and/or manufacturing processes for a biological drug in a GMP facility.
  • 4+ years of experience in isolation and culturing human primary cells.
  • 4+ years of experience in developing autologous cell therapies or tissue engineered products.
  • Hands-on analytical experience using techniques such as RNA/DNA purification, PCR, qPCR, multi-color flow cytometry, cell counting, and cell-based assays.
  • Experience designing primers and probes for qPCR and gene expression analysis.
  • Advanced expertise in product, process and test method development as well as mechanical design, prototyping, biomaterials.
  • Technical ability to turn design ideas into product/process improvements.
  • Proficient in CAD software, preferably AutoCAD and MATLAB
  • Good leadership and people skills, teamwork experience, and demonstrated conflict handling and resolution ability and negotiation skills.
  • Good achievement and record in scientific research and technical development as evidenced by research paper, conference presentation, and patent publications.
  • Self-motivated, organized, familiar with the relevant literature, attention to details.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Senior Manager, Strategic Corporate Finance and FP&A Finance and Accounting Cambridge 05/26/2021

Senior Manager, Strategic Corporate Finance and FP&A

Vericel, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Corporate Finance and FP&A professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet.  This highly motivated finance professional will lead financial planning and analysis for our core cell therapy commercial business, our pipeline, and potential business development opportunities.  Reporting directly into the Executive Director of FP&A and Investor Relations at Vericel, this individual will also have an opportunity to support Investor Relations at Vericel, a $2 Billion+ market cap company with a strong institutional shareholder base.  In addition, this finance professional will also have direct exposure to the CFO and CEO of Vericel.

The Senior Manager of Strategic Corporate Finance and FP&A will be responsible for leading corporate and financial planning across Vericel to drive and support the company as it continues to focus on maintaining its high growth profile, across both its current portfolio as well as through potential business development.  In addition, the Senior Manager will support business strategy and decision making, develop robust financial models, and play a key role in supporting the CEO, CFO and Executive Director as well as the Executive Leadership team at Vericel.

In this highly visible role, the Senior Manager will work cross-functionally with leaders across the company to drive both our annual and multi-year corporate planning processes.  Additionally, the Senior Manager will lead key FP&A activities, 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.

Key Responsibilities:

  • Develop, maintain and enhance long term financial model for the company and analyze how investments/changes/strategic scenarios could impact multi-year P&L and value creation
    • Enhance and maintain current year and multi-year corporate model for company
    • Standardize inputs and outputs to ensure model can easily be updated on a regular basis
    • Valuation analysis of existing business and potential strategic transactions using multiple valuation techniques and comparison of company to peers on multiple key metrics
  • Support Business Development & Strategic Transactions
    • Work closely with Executive Director of FP&A and IR 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
    • Create financial analysis for potential business development opportunities including potential pro forma impacts to business
    • Provide financial analysis for other strategic financial and ad/hoc projects
  • Increase decision support across business
    • Ensure we are supporting brands/functions/company to ensure we are optimally investing to achieve highest growth while maintaining strong profitability profile
    • Build out a process for business cases for new areas of investment, capital expenditure requests with a P&L view/mindset and consistent financial metrics
    • Partner with brands/functions - Increase partnership and resources for 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
  • Improve financial planning, analysis and reporting to keep up with pace of company growth
    • Play lead role in inputs/coordination for Quarterly Forecasts, Annual budgets, LRP inputs/data entry, etc.
    • Maintain key reports/dashboards
    • Prepare key monthly financial reports for ELT and Functions, including analyses of current performance
  • Help to support Investor Relations function and execution
    • Work with Executive Director to be a key contributor to Investor Relations activities
    • Help with preparation of quarterly earnings materials
    • Increase market intelligence and analysis for stock performance, IR reporting and benchmark versus peers

Key Skills Required for Position:

  • 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
  • Experience in banking, consulting and/or life sciences preferred
  • Commercial and/or R&D finance life sciences experience preferred but not required
  • MBA preferred

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Senior Medical Director, Burn Care Franchise Medical/Clinical Pharma Cambridge 06/09/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Medical professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Chief Medical Officer at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

The Senior Medical Director, Burn Care Franchise, will be responsible for providing medical expertise regarding all aspects of burn care at Vericel.  She/he will report to the Chief Medical Officer and be the primary medical interface between the Company and burn surgeons, nurses and other healthcare professionals, and will support educational activities, scientific/clinical development and the Company’s field-based Burn Care Medical Affairs and Commercial teams.

ESSENTIAL FUNCTIONS

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Operational

  • Support the Chief Medical Officer, providing medical expertise regarding all aspects of burn care at Vericel.
  • Serve as the primary medical interface between the Vericel Clinical team and practicing burn surgeons, nurses and other healthcare professionals.
  • Develop and execute the Clinical and Medical Affairs strategy for the Burn Care Franchise.
  • Work collaboratively with and support the field-based Medical Science Liaisons on the Burn Care team.
  • Provide strategic support and direction to the Epicel and NexoBrid Brand teams and day-to-day support to the Burn Care Specialists on the Commercial team.
  • Provide education on the management of patients with burn injuries to internal Vericel teams and external audiences.
  • Attend appropriate conferences and monitor the scientific literature for changes in clinical practice and scientific advances that may influence future activities and strategic direction of the Burn Care Franchise.  .
  • Provide strategic and executional support to the Clinical Operations and Medical Affairs teams during the planning and execution of pre- and post-market clinical trials and evidence development activities.
  • Present brand related outcomes data and updates at professional conferences as appropriate.
  • Serve as an interface between Vericel and relevant professional organizations such as the American Burn Association, North American Burn Society, the U.S. Food & Drug Administration and other regulatory authorities as required.
  • Provide input as required to Business Development team for the burn care franchise with respect to strategic direction as well as in-depth assessments of additions to product portfolio including line extensions.
  • Work in close collaboration with Commercial Team including Marketing, Advocacy Development and Sales Training in the development and communication of educational content to both internal and external stakeholders.

Financial

  • Assist in forecasting, planning and execution of departmental budget and ensure that monthly expenses are in line with the budget.

Leadership Qualifications

Vericel is committed 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 locations where we conduct business, as well as our Vericel’s internal 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.
  • Serving as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Qualifications:

  • MD with 10 years clinical experience as Board Certified burn surgeon.
  • Demonstrated expertise in clinical research, project development and execution and ICH Good Clinical Practice requirements.
  • Excellent verbal, presentation, and written communication skills.
  • A track record of clinical and scientific publications.
  • Experienced leader with collaborative management style, motivational and fair with skills in diplomacy, consensus building, negotiation, problem solving and the ability to gain confidence and trust of others.
  • History of successful industry experience.

WORKING CONDITIONS AND PHYSICAL DEMANDS

Expected to travel up to 70% and live within 30 miles of major airport hub

 

 

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Validation Supervisor Engineering Cambridge 06/03/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Validation professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Validation at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

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 in a GMP biotech manufacturing facility.

ESSENTIAL FUNCTIONS

Core Responsibilities:

This position requires both individual responsibilities and supervision of validation engineers, including:

  • Manage validation department personnel including performance evaluation, career development, mentoring and coaching
  • Lead Validation group meetings and collecting and monitoring validation group performance metrics
  • Lead complex validation projects, and the validation aspects of multi-departmental projects
  • Ensure timely execution and closure of scheduled requalifications
  • Ensure timely completion of project activities, including development of system lifecycle documentation, risk assessments, qualifications, and reports.
  • Identify and implement improvements to validation systems
  • Supervise the calibration system and Calibration Coordinator to ensure that scheduled and ad hoc calibrations are performed as required
  • Serve as subject matter expert (SME) for facilities, utilities, and equipment commissioning and qualification (C&Q)
  • Train Validation Engineers on validation concepts and techniques
  • Support investigations into failures of qualified systems, leading as appropriate
  • Develop and revise Validation SOPs to maintain the system in a state of compliance and efficient operation
  • Write, review, and approve validation documentation, including protocols and reports
  • Stay current with industry guidance documents and trends impacting Validation
  • Establish and support a culture of compliance, professionalism, and high performance within the Validation group

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.

Basic Qualifications:

  • Bachelor's Degree or equivalent and 6+ years of validation experience, or
  • Master’s Degree or equivalent and 4+ years of validation experience.
  • 3-4 years of experience 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.
  • Prior experience supervising personnel.

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.

Able to lift up to 40 lbs

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now

NASDAQ: VCEL

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June 24, 2021
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