Manufacturing Compliance Specialist, Cell Therapy
About The Position
At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Position Summary The Compliance Specialist provides support for projects, manufacturing execution, computer systems (GP, EBR, OpCenter APS), quality systems (deviations, change controls, CAPAs) and implementation of lean/continuous improvement initiatives within the Manufacturing department. Schedule: This position is in-office from Monday – Friday between our new Burlington, MA office and our Cambridge office.
Requirements
- BA/BS in a scientific discipline or equivalent experience preferred.
- 2-5 years of experience in a biopharmaceutical manufacturing environment.
- Familiarity with computer systems such as OpCenter, ERP, EBR and Veeva.
- Must be familiar with biopharmaceutical equipment and manufacturing systems.
- Knowledgeable of Current Good Manufacturing Practices and regulatory requirements.
- 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.
Nice To Haves
- Lean Six Sigma Certification or Experience
- Root Cause Analysis, GEMBA Problem Solving or equivalent certification or experience
- Experience with Human Error Prevention Programs (HEPP).
- Basic laboratory skills, including working with mammalian cell culture
- Experience working in an ISO 7 cleanroom environment.
Responsibilities
- Coordinate and ensure successful completion of manufacturing projects.
- Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner where applicable.
- Lead investigations and provide trouble shooting for deviation reports.
- Own Change Control Records or assist manufacturing change owner for changes impacting the process.
- Assess process manufacturing performance by observation of the floor operations and review of performance data with the objective of implementing process improvement solutions.
- Assist in generation of training materials and may assist in providing training on technical aspects of the manufacturing process.
- Responsible for implementation of corrective actions.
- Assist with the execution of validation protocols.
- May participate in regulatory inspections and/or the implementation of corrective actions arising from inspections.
- Participate in tech transfer activities; assess documentation, materials, training, procedures and systems modifications.
- Lead or participate on the assessment or implementation of special initiatives, including Lean tools or process improvements.
- Represent Manufacturing on cross-functional teams. Collaborate with other departments including QA, QC, Engineering, Validation, Material Management and Project Management.
Benefits
- Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
- Career Growth: Be a part of a growing organization with opportunities to expand your impact
- Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
