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Position Department Location Date
Accounting and FP&A Manager Finance and Accounting Cambridge 12/10/2019

Accounting and FP&A Manager

Integral manager in the Finance and Accounting department who will directly oversee inventory cost accounting analysis and revenue payer analysis with project-based responsibilities for the FP&A Senior Director. This position reports to the Controller.

Essential Functions:

• Analyze current cost accounting processes including inventory management, mapping processes and provide recommendations for future process changes

• Oversee SOX controls in inventory

• Analyze inventory transactions to ensure that all are appropriately recorded in sub-ledgers and general ledger. Includes the monthly recording of inventory reserve adjustments.

• Complete account analyses and monthly balance sheet reconciliations for areas of responsibility

• Contribute to monthly corporate forecasting and annual budgeting with emphasis on gross margin and working capital requirements

• Prepare related audit schedules and other requests from external auditors and partners

• Educate management on the inventory process

• Create process to analyze AR collection trends and identify opportunities for improvement

• Assist the Senior Director in identifying drivers of net product price movements

• Assist in revenue forecasting

• Analyze monthly revenue results compared to budget & prior year for revenue streams

• Preparation of ad hoc FP&A projects including preparation of a forecasting model for expected product launch in 2021

• 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:

• Bachelors degree in Finance or Accounting.

• 5+ years of a combination of public accounting and industry accounting experience.

• Big 4 public accounting experience required

Preferred Qualifications:

• Manufacturing accounting experience preferred

• CPA preferred

Working Conditions and Physical Demands:

  • Minimal travel to Ann Arbor, MI

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
Burn Nurse - Clinical Research Liaison - Midwest Clinical Research Midwest - Homebased 11/21/2019

Position Summary:

• Responsible for directing and managing the internal and external resources, clinical study sites and CROs to optimize recruitment to study.

• Responsible for providing Clinical front-line case support and Education to burns centers.

Essential Functions:

Clinical Recruitment Manager (50% time)

• Ensure the timely execution of the recruitment plan for U.S. sites participating in the study.

• Complete training on study protocol, electronic Clinical Report Forms, medical training (Including clinical data gathered to-date), all study guidelines (of all vendors), sites’ contracts and budget.

• Engage with principal investigators and site teams / staff via face to face visits, by phone, email

• Build strong relationships with site investigators and site teams/staff

• Support training to the clinical sites

• Provide timely updates to the Vericel’s Clinical Operations team and Clinical Program Manager (CPM)

• Support the operation of clinical studies and serve as a liaison between the medical centers. and the CRO

• Address, in in coordination with Vericel’s Clinical Operations Team, CPM and the CRO, any operational and performance issues

• As needed, assist the Company’s local Clinical Research Associate and/or medical monitor

• Arrange and lead meetings with U.S. PIs and medical staff in collaboration with the CRO

• Support the CRO in identification and selection of qualified investigational sites in the U.S.

• Attend annual scientific meetings and present data as applicable

• Ensure compliance with Clinical Good Practices and other applicable requirements

Clinical Support Manager (50% time)

• Enhance clinical/scientific knowledge of product through appropriate scientific exchange, publications, podium presentations and abstracts.

• Participate in medical education for healthcare professionals through presentations at office visits, investigator meetings, advisory boards, medical meetings, and other appropriate venues to enhance product and disease state knowledge.

• Collaborate with clinical team and Burn team specialists to coordinate and optimize educational and research support for sites/investigators participating in Vericel clinical trials.

• Respond to unsolicited requests regarding interest in investigator sponsored studies (ISS), and support ISS submissions through appropriate internal processes.

• Responds to unsolicited request for medical information associated with supported products and disease state areas.

-Provide clinical support for patients receiving Vericel products:

  • Full engagement in and intimate knowledge of the care of burn patients from admission through discharge
  • Support for various operating room procedures involving product patients, including:
  • Product placements
  • Dressing changes
  • Take-downs
  • Other miscellaneous

• Awareness of and impact on burn centers’ evolving patient population

-Intimate knowledge of various burn product utilization protocols at facilities

• Clear understanding of product’s role(s) within these protocols

• Product use and interactions with other products

• Availability of medical supplies at key at active accounts that are compatible with product

-Train and support all appropriate staff in active accounts and select prospect accounts

-Engage with Key Opinion Leaders (KOLs) in the burn treatment field

Qualifications, Education, and Experience:

Required Education and Experience:

• Strong interpersonal, management, cross-functional and organizational skills required

• Bachelor or higher nursing degree with 3 years plus clinical experience as a burns nurse

• Pharmaceutical / Medical Device Industry experience in a relevant discipline

• Clinical research experience in the pharma / biotech / medical devices industry.

• Practical knowledge of FDA regulations on good clinical practices (GCP) required.

• Practical knowledge of International Conference on Harmonization (ICH)-GCP guidelines for clinical trials required.

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.

Working Conditions and Physical Demands:

• Must be able and willing to travel nationally and be located within 30 miles of a major airport hub (s) in the Midwest region of the United States.

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
Burn Nurse - Clinical Research Liaison - West Coast Clinical Research West Coast - Homebased 11/14/2019

Position Summary:

• Responsible for directing and managing the internal and external resources, clinical study sites and CROs to optimize recruitment to study.

• Responsible for providing Clinical front-line case support and Education to burns centers.

Essential Functions:

Clinical Recruitment Manager (50% time)

• Ensure the timely execution of the recruitment plan for U.S. sites participating in the study.

• Complete training on study protocol, electronic Clinical Report Forms, medical training (Including clinical data gathered to-date), all study guidelines (of all vendors), sites’ contracts and budget.

• Engage with principal investigators and site teams / staff via face to face visits, by phone, email

• Build strong relationships with site investigators and site teams/staff

• Support training to the clinical sites

• Provide timely updates to the Vericel’s Clinical Operations team and Clinical Program Manager (CPM)

• Support the operation of clinical studies and serve as a liaison between the medical centers. and the CRO

• Address, in in coordination with Vericel’s Clinical Operations Team, CPM and the CRO, any operational and performance issues

• As needed, assist the Company’s local Clinical Research Associate and/or medical monitor

• Arrange and lead meetings with U.S. PIs and medical staff in collaboration with the CRO

• Support the CRO in identification and selection of qualified investigational sites in the U.S.

• Attend annual scientific meetings and present data as applicable

• Ensure compliance with Clinical Good Practices and other applicable requirements

Clinical Support Manager (50% time)

• Enhance clinical/scientific knowledge of product through appropriate scientific exchange, publications, podium presentations and abstracts.

• Participate in medical education for healthcare professionals through presentations at office visits, investigator meetings, advisory boards, medical meetings, and other appropriate venues to enhance product and disease state knowledge.

• Collaborate with clinical team and Burn team specialists to coordinate and optimize educational and research support for sites/investigators participating in Vericel clinical trials.

• Respond to unsolicited requests regarding interest in investigator sponsored studies (ISS), and support ISS submissions through appropriate internal processes.

• Responds to unsolicited request for medical information associated with supported products and disease state areas.

-Provide clinical support for patients receiving Vericel products:

  • Full engagement in and intimate knowledge of the care of burn patients from admission through discharge
  • Support for various operating room procedures involving product patients, including:
  • Product placements
  • Dressing changes
  • Take-downs
  • Other miscellaneous

• Awareness of and impact on burn centers’ evolving patient population

-Intimate knowledge of various burn product utilization protocols at facilities

• Clear understanding of product’s role(s) within these protocols

• Product use and interactions with other products

• Availability of medical supplies at key at active accounts that are compatible with product

-Train and support all appropriate staff in active accounts and select prospect accounts

-Engage with Key Opinion Leaders (KOLs) in the burn treatment field

Qualifications, Education, and Experience:

Required Education and Experience:

• Strong interpersonal, management, cross-functional and organizational skills required

• Bachelor or higher nursing degree with 3 years plus clinical experience as a burns nurse

• Pharmaceutical / Medical Device Industry experience in a relevant discipline

• Clinical research experience in the pharma / biotech / medical devices industry.

• Practical knowledge of FDA regulations on good clinical practices (GCP) required.

• Practical knowledge of International Conference on Harmonization (ICH)-GCP guidelines for clinical trials required.

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.

Working Conditions and Physical Demands:

• Must be able and willing to travel nationally and be located within 30 miles of a major airport hub (s) on the West Coast of the United States.

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 11/21/2019

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 Functions:

  • 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.

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
Cell Therapy Specialist - MACI Sales-MACI Hartford, CT- Homebased 11/12/2019

Core Responsibilities:

  • Call on orthopedic surgeons and specialists in cartilage repair 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.
  • Work with Company’s benefits coordinator to facilitate and understand product and procedure reimbursement across different insurance carriers and facilities.
  • Other projects and assignments as needed.

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:

  • Must live in the Greater Hartford, Connecticut area, including Stamford, Bridgeport or New Haven.
  • Territory includes Upstate New York, including Westchester County (excluding NYC and Long Island), Connecticut and Rhode Island.
  • Bachelor’s Degree, with a science, business or marketing degree preferred.
  • Knowledge of anatomy and physiology strongly desired in order to understand where and how products work clinically (orthopedic background is preferred).
  • Candidate will need to undergo and successfully pass hospital credentialing requirements in order to perform certain aspects of their job as a Cell Therapy Specialist. This typically involves 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 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.
  • 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:

  • Must manage significant regional travel demands.

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
Director, Validation Quality Assurance Cambridge 10/30/2019

Department Description:

The Validation Department provides documented evidence that Operational equipment, systems, and processes involved in commercial product manufacturing, perform in a qualified and reproducible manner and comply with regulatory compliance requirements and current industry/Vericel policy and guidance. The deliverables of the Validation Department include approved Validation protocols and Final Reports. The department also functions as the liaison with Metrology/Calibration Vendors and performs all equipment ownership and quality review responsibilities associated with site calibration activities.

Position Summary:

This position is responsible for the oversight and management of the deliverables of the Validation and Quality System Departments which includes: supporting validation for computer systems, equipment, utilities, cleaning, sterilization, and processes and equipment requalification. Additionally, this position will have oversight of Change Control, Product Quality Reviews, Management Reviews and Risk Management. This position directs the development, planning, implementation and maintenance of validation methods, processes and operations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Oversees department schedules, ensuring compliance with appropriate regulatory agency requirements, internal company policies and current industry practices.

Essential Functions:

Staff Management:

  • Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
  • Provide career development and guidance to direct reports. Identify training requirements/needs and job related qualifications.
  • Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
  • Coach and mentor staff in all aspect 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.

Budget:

  • Provide input into budget forecasting when appropriate.

Department Management:

  • Establish, maintain and report applicable department or organizational metrics which drive accountability.
  • Accountable for project completions and achievement of compliance goals relative to deviations, change controls, CAPA and effectiveness reviews.
  • Represent department in Project Team meetings.
  • Interact with project teams and cross-functional groups.
  • Address and/or escalate site compliance problems and issues to senior department management.
  • Lead and facilitate meetings/workshops.
  • Participate in the integration of new computer systems and processes.
  • Responsible for keeping department in audit ready condition at all times.

Additional Responsibilities:

  • Ensure compliance with appropriate internal and regulatory policies and procedures. This includes product documentation, specifications, and all regulatory requirements.
  • Responsible for the creation of validation master plans, and integrated commissioning and qualification plans. Reviewing and approving commissioning and validation documents in accordance with current GMPs.
  • Determine and develop validation approaches and resolve complex validation issues, working closely with cross functional teams to address deviations as well as recommend and implement corrective and preventative actions.
  • Execute major validation projects and ensure adherence to schedule.
  • Communicate validation requirements, timelines, and resource needs to senior management.
  • Work closely with the project team members, including Manufacturing, Engineering, and Quality to incorporate the appropriate elements of quality, equipment and production into validation strategies.
  • Oversee training and development of staff to ensure compliance with site procedures and regulatory expectations.
  • Develop department goals.
  • Present validation documents and strategies to Senior Management and regulatory agencies when required.
  • Set ambitious and achievable targets to drive for results based on organizational objectives.
  • Build effective cross functional relationships.
  • Interface with peers and colleagues internal and external to identify and implement best practices.
  • Complete/support corrective action plans which address deficient areas identified and ensure adherence to compliance regulations.
  • Organize staff and workload distribution to meet or exceed productivity performance standards.

Basic Qualifications:

  • Engineering/science Bachelor’s degree with a minimum of 12 years of experience in the industry (10 years Validation/Quality) or a Master’s degree with a minimum of 10 years of experience in the life sciences regulated industry (8 years Validation/Quality).
  • A minimum of 8 years of experience in a supervisory or management role.
  • Experience of working in a GMP environment and knowledge of ICH Q8, Q9, Q10 and FDA, ISO and cGMP regulations.
  • Application of risk based approach to validation (FMEA, PHA, etc.).
  • Knowledge of Validation Lifecycle Approach, such as ASTM E-2500.
  • Experience contributing to regulatory documents development.
  • Excellent technical writing and presentation skills.
  • Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio.
  • Experience supporting internal and external audits and oversee closure of all gaps identified during the audits.

Preferred Qualifications:

  • Strong facilitation and team building skills.
  • Energetic in the pursuit of improved processes and ultimately improved performance.
  • Natural leader/influencer, adaptable, flexible as well as a pragmatically minded problem solver.
  • Competent technical knowledge of bio-pharmaceutical plants and manufacturing processes.
  • Innovative and capable of developing alternative solutions to issues at hand.
  • Good communication skills at organization, team, and individual levels.

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
Document Specialist II Quality Assurance Cambridge 11/21/2019

Position Summary:

Work with primary originators of documentation to ensure that documentation is written, edited, reviewed, and approved in compliance with cGMP.

Core Responsibilities:

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

Leadership Qualifications:

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

Preferred Qualifications:

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

Working Conditions and Physical Demands:

  • Ability to lift and carry up to 40 lbs
  • May require 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
Engineer III Engineering Cambridge 11/22/2019

Department Description:

The Engineering department is primarily responsible for the detailed design, startup, troubleshooting, commissioning, optimization and lifecycle support of manufacturing equipment, facilities, and utility systems.

Essential Functions:

Core Responsibilities:

  • Lead Engineering specification, estimating, design, procurement, programming, installation management, startup, commissioning, and documentation of new systems and the ongoing support of existing systems.
  • Provide cost estimates for new systems and equipment, and modifications or upgrades to existing systems.
  • Lead design reviews, construction projects and installation support.
  • Perform engineering startup, factory acceptance testing, commissioning, documentation, validation support and operator training.
  • Provide day to day engineering support for process equipment such as Biosafety Cabinets, Cold Storage, Incubators, Ovens, Autoclaves, Heat Sealers, etc.
  • Provide day to day engineering support for plant equipment such as RODI Water Systems, Vacuum Pumps, Air Compressors, HEPA Filtration, HVAC, etc.
  • Create and edit SOPs and Quality System Records based on understanding of GMP Facility systems and Engineering Standards.
  • Create engineering Reports and Protocols.
  • Provide support for BMS controls, industrial process instrumentation and PLC control.
  • Develop and maintain corporate engineering specifications, drawings and standards.
  • Provide leadership, guidance, and direction to junior staff consistent with cGMP, good Engineering practices, and company corporate quality governance.
  • Take a lead role in Engineering projects, by prioritizing work, developing work plans, and participating in cross-functional teams.
  • Serve as an Engineering department SME where required, including audits, change controls, and deviation investigations.
  • Provide expertise in process equipment design, specification development and installation of such equipment and systems.
  • Author, review, and/or manage change controls and equipment deviations pertaining to the Engineering department in Trackwise.
  • Act as Trackwise subject matter expert for Engineering department.
  • Support the Facilities team in helping to troubleshoot utility and equipment problems, including outside normal working hours if necessary
  • 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 in Mechanical, Chemical or Biomedical Engineering or equivalent engineering field or technical science and 3 or more years of relevant experience. Alternatively, a Master’s degree in an applicable field with 2+ years of relevant experience.
  • Experience with commissioning, servicing and maintaining equipment in GxP environments.
  • Experience with MS Office: Outlook, Word, Excel, PowerPoint.
  • Experience in writing and editing Technical Reports and Protocols.
  • Experience with Quality Systems.

Preferred Qualifications:

  • Proficient in CAD software, preferably AutoCAD.
  • Exhibits strong communication stills and the ability to work in a cross-functional team environment.
  • Experience with HVAC and related control systems.
  • The ability to react to changing priorities based on manufacturing or business needs.

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.
  • Required to work with hand tools.
  • Work includes some lifting, up to 50 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
Engineer, Validation I Engineering Cambridge 12/03/2019

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.

Core Responsibilities:

  • Perform validation activities in the media preparation, cell culture, utilities and QC areas of a cGMP biotech manufacturing facility.
  • Perform hands on execution of Installation, Operational and Performance Qualifications for equipment, facilities, utilities, as well as cleaning, sterilization, and manufacturing processes in accordance with predefined test protocols.
  • Analyze validation results and compile data into reports for initial qualifications and re-qualifications.
  • Coordinate testing schedule with impacted area managers and quality control based on project needs.
  • Provide input to technical composition of standard operating procedures.
  • Generate custom validation protocols, execute protocols and write final reports.
  • Create department standard operating procedures.
  • Investigate and troubleshoot validation problems.
  • Participate in equipment failure investigations, corrective/preventive actions and equipment release.
  • Play a lead role in the successful completion of project milestones and crucial technical tasks.
  • Provide assistance with Calibration and Metrology liaison responsibilities as department needs require.
  • Routine and effective communication with immediate supervisor and other personnel within the group in addition to outside the department.
  • Review and approve validation documentation.
  • 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:

  • Bachelor's Degree or equivalent work experience and 2+ years validation experience OR Master’s Degree and 1+ year validation experience.
  • 1+ 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 and final reports and managing validation projects.
  • Ability to read/interpret engineering drawings and design documents.
  • Knowledge of risk management tools and techniques.

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.

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
Manager, Regulatory Affairs Regulatory Cambridge 11/22/2019

The Manager, Regulatory Affairs manages, evaluates and completes regulatory projects consistent with the company goals. Responsible for timely planning and coordination of regulatory submissions. Provides guidance to cross-functional teams on regulatory strategy and tactics. Keeps abreast of regulatory procedures and practices. This position will work independently with appropriate oversight and is expected to identify and act on activities without requiring immediate direction.

Essential Functions:

• With minimal supervision, plan and manage regulatory activities related to assigned development projects. Assist in developing and implementing strategies for the earliest possible approvals of regulatory submissions associated with assigned development projects.

• Manage the assembly and timely submission of INDs, BLAs, MAAs and other dossiers as required for investigation and registration of medical products in the US and abroad.

• Ensure regulatory submissions are maintained in compliance with regulatory requirements.

• Represent the company in its dealings with the FDA and other regulatory authorities, as appropriate.

• Participate on project teams and provide expertise on regulatory matters.

• Develop and maintain current regulatory knowledge and advise management of significant developments.

• Assist in SOP generation and contribute to improvements in department best practices.

• Perform other duties as required, interfacing with other departments, CROs, and external vendors as needed.

Qualifications, Education, Experience:

• Bachelor of Science in a scientific discipline.

• 3+ years direct Regulatory Affairs experience for pharmaceutical, biotech, or medical device products in the US market.

• Combination product experience a plus.

• Experience and knowledge in preparation of INDs, BLAs, and supportive amendments and supplements.

• Working knowledge of FDA and ICH regulatory guidance and regulations. Understanding of FDA structure and function.

• Working knowledge of eCTD elements and structure.

• Strong regulatory writing skills and use of Microsoft Word.

• Strong team player that has a customer service approach and is solution oriented.

• Attention to detail and the ability to work individually, within a multidisciplinary team, or with external partners and vendors.

• Possess excellent 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
Medical Science Liaison Medical/Clinical Pharma West Coast - Homebased 10/11/2019

Position Summary:

The Medical Science Liaison (MSL) will be responsible for providing non-promotional scientific, educational, and research support for the Vericel Orthopedic portfolio.

Essential Functions:

  • The MSL will be responsible for developing and maintaining relationships with key orthopedic experts and building a well-informed advocacy base for the Vericel Orthopedic franchise.
  • The MSL will act as a conduit for providing accurate and updated clinical, scientific and medical information to key orthopedic experts, health care professionals, treatments decision makers and other members of the scientific, provider and payer community (private insurance, payers, medical groups, government agencies, and health systems with drug formularies), in compliance with all relevant company policies.
  • Maintain business and clinical knowledge of the orthopedic/cell therapy treatment landscape including current treatment strategies, current and pending competitors, and new therapeutic developments through, among other means, attending relevant symposium and scientific conferences as well as reviewing key journals.
  • Identify, establish, and maintain collaborative relationships with key experts, investigators and institutions strategic to product development.
  • Participate in medical education for healthcare professionals through presentations with customer visits, investigator meetings, advisory boards, medical meetings, and other appropriate venues to enhance product and disease state knowledge.
  • Collaborate with the research and clinical teams to coordinate support for sites/investigators participating in Vericel clinical trials.
  • Support and guide requests for investigator sponsored studies (ISS) through appropriate internal processes.
  • Respond to unsolicited requests for medical information by providing effective clinical presentations tailored to meet specific needs of the requestor.
  • Identifies and communicates key clinical and research issues and insights from industry leaders to appropriate departments to help shape company research, development, and strategies for investigational and commercialized products.
  • Facilitate the identification of medical community educational needs around cartilage treatment management, including awareness and understanding of appropriate/inappropriate use of company products.
  • Maintains clinical expertise through comprehensive education including attendance at relevant symposium, scientific workshops, and review of key journals.
  • Participation in required internal training, presentations and journal clubs. Maintains appropriate communication with Clinical, Regulatory, and Legal personnel within the company to ensure appropriate timelines and procedures are met.
  • Adheres to regulatory and compliance guidelines and company policies in all aspects of scientific dissemination of information to include responses to unsolicited requests for medical information.

Qualifications, Education, and Experience:

  • MS, Physical Therapy degree, RN/BSN, MD, PhD or PharmD
  • Experience working with orthopedics or cell therapies.
  • 2+ years of experience as a Medical Science Liaison or a related field.
  • Must live West of Mississippi river, and within 30 miles of a major airport.
  • Strong verbal and written communication skills.
  • Well-versed in clinical and basic science to be able to deliver cutting edge data and technical/practical education to Health Care Professionals (HCP).

Working Conditions and Physical Demands:

  • Must be able to drive a company car.
  • Must be able and willing to attend surgical procedures.
  • Must be able to pass hospital credentialing requirements.
  • Must be able to lift and carry instrument trays, surgical supplies and training supplies, up to 40 lbs.
  • Ability to travel up to 70% of the time on the East Coast of the United States, including occasional weekend travel for conferences and meetings.

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
Regulatory Operations Manager Regulatory Cambridge 11/22/2019

Position Summary:

The Manager of Regulatory Operations will oversee daily regulatory information management (RIM) and submission activities for the organization. They will serve as the primary liaison with our submission vendor. The manager will also assist with various information management system activities including administration, change control, implementations, and related activities within and adjacent to regulatory systems. Additional legacy content migration tasks as required. The incumbent will work independently with appropriate oversight. They are expected to identify and act on activities without requiring immediate direction.

Essential Functions:

  • Primarily use an advanced Regulatory Information Management (RIM) system, Veeva Vault for most activities and tasks.
  • Facilitate submission vendor activities, support submission planning and management, execute ongoing RIM optimization, and other special projects as required.
  • Organize, stage, import, index, archive, and manage submission and related regulatory documentation. Collaborate with both internal and external stakeholders to ensure on-time and compliant delivery of various submissions.
  • Create, update, and manage submission information records within the RIM system. Run/analyze reports and provide status updates during cross-functional team meetings.
  • Suggest process optimization changes, identify procedural gaps, and assist with the development of best practice documentation.
  • Occasionally use specialized Adobe Acrobat tools (TRS Toolbox) to generate and review submission-ready documents. This may also include moderate use of regulatory authoring templates (StartingPoint).
  • Operate within the new paradigm of regulatory operations leveraging strategic resourcing wherever possible.

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.

Education:

  • Bachelor’s Degree required.
  • Advanced degree (or progress towards one) preferred.

Experience:

  • 4-6 years direct Regulatory Operations required.
  • 2+ years experience with Electronic Document/Content Management Systems (eDMS, eCMS). System management and/or administration with Veeva Vault products highly desired.
  • Good understanding of regulatory information management (RIM) and eCTD principles and practice.
  • High level of expertise in Microsoft Suite of products, Adobe Acrobat and TRS Toolbox.
  • Technical knowledge of document/report publishing, regulatory submissions, and quality control tasks.
  • Knowledge of the drug development process, eCTD/ICH requirements, and related guidance.
  • Direct experience with US regulatory applications (BLA, IND, HDE) required. Ex-US submission experience desired.
  • Very strong attention to detail.
  • Ability to balance multiple tasks to meet priorities and timelines.
  • Excellent 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
Sales Operations Associate Marketing Cambridge 11/22/2019

Essential Functions:

  • Coordinate on-boarding of all new sales personnel with internal departments.
  • Administer all sales training content through company’s Learning Management System.
  • Primary administrative resource for two sales teams (first point of contact).
  • Provide logistical support for all sales training meetings and events.
  • Work with marketing to provide regular updates to brand websites.
  • Work with marketing to provide logistical support for tradeshows, surgeon training programs and other commercial programs/events.
  • Manage various sales support activities and projects as assigned under the guidance of Sales Operations and Leadership management.
  • Promotional material management and distribution to the sales force.
  • Process and track department invoices.
  • Adherence to all relevant internal and external policies and guidelines related to the team’s activities and deliverables.

Leadership Qualifications:

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

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

Required Education and Experience:

  • BS or BA (Business Administration or Marketing preferred) with a 1+ years of experience in a marketing or sales environment. Experience with pharmaceutical, biotech or medical device company a plus.
  • Experience with MS Office, including proficiency with Excel and Powerpoint as well as Adobe Acrobat Pro, eProcurement, Veeva Systems, Adobe Connect and/or Concur Excellent communication skills both oral and written.
  • Must be able problem solve and operate in a dynamic environment / fast paced environment.
  • High attention to detail and precision in creating reports and conducting analyses.

Preferred Qualifications and Experience:

  • Ability to manage projects for inception to implementation.
  • Ability to conduct topical research by synthesizing information from multiple sources (academic journals, on-line media and publications, etc.) analyze information and create relevant reports.
  • Ability to edit copy and materials to create consistency with established brand messaging and to meet the needs of specific audiences.
  • Vendor management experience.

Working Conditions and Physical Demands:

  • Willingness to travel domestically, 2-4 trips per year.

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, R&D Research and Development Cambridge 12/03/2019

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 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 principles and professional practices, to solve a wide range of complex problems in creative and practical ways.
  • Leads cross-functional development teams and provides scientific 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 regards 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 8+ years of related work experience, or
  • MS and 6+ years of related work experience, or
  • Ph.D. or equivalent in Biology, Biochemistry, Biomedical engineering, Pharmaceutical Sciences or related fields and 4+ years of related work experience.
  • Advanced expertise in mammalian cell culture and related techniques.
  • Familiarity with technical writing and statistical analysis to produce research 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.
  • Experience with medium development, cell banking methods and development of cell-based assays.
  • 2+ years of experience in developing autologous cell therapies or tissue engineered products.
  • Extensive hands-on experience in analytical methods for protein, RNA and DNA analysis.
  • Prior experience in cGMP environment and clean room requirements.
  • Prior success with cell-based assay development.
  • Good leadership and people skills, team work 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

NASDAQ: VCEL

$18.38 -0.12 (0%)
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December 10, 2019
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