Senior Associate, Cell Therapy Manufacturing

Job Description

Job Description

This role will be based in our Cambridge, MA location until our new state of the art facility located in Burlington, MA is ready.

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

POSITION SUMMARY

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

DUTIES AND RESPONSIBILITIES :

• Perform manufacturing procedures inside a manufacturing clean room in accordance with established SOPs, cGMPs, and safety regulations.
• Qualified to perform aseptic manipulations of cell culture operations.
• Document all operations in Electronic Batch Records and log sheets according to cGMPs and established SOPs.
• Maintain manufacturing-controlled areas in an inspection ready state. Perform clean room equipment sanitization.
• Record equipment and facility metrology data to ensure the equipment operates within specifications. Report out of specification readings to production management.
• Able to work independently upon completion of training. Be receptive to feedback and guidance from manager and other more experienced staff.
• Ability to organize, plan and manage time to effectively complete daily tasks. 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.
• Able to make cell-culture decisions based on cell observations and guidelines in written procedures.
• Assist in reviewing and revising production documents (SOP’s and electronic records).
• Fully trained in at least one unit operation in both product lines.
• Ability to identify and report deviations and contribute to deviation investigations.
• In addition to being fully qualified in MACI or Epicel manufacturing process, cross train and qualify in at least 5 core competencies e.g. 3T3, Media Prep, GP, TrackWise, Veeva.
• Achieve Qualified Trainer status.
• Serve as a technical resource for questions and / or investigate manufacturing issues.
• Able to take on small project work and coordinate with teams in completing the project.
• Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Preferred Qualifications :

WORKING CONDITIONS AND PHYSICAL DEMANDS

EEO Statement

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 / Affirmative Action Employer.

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