Senior Associate, Cell Therapy Manufacturing

Vericel • Cambridge, MA

35d • $30 - $37 • Onsite

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). Schedule: This position is in-office Wednesday-Saturday. Location: This role will be split between our new, state of the art facility located in Burlington, MA and our current location in Cambridge, MA. Position Summary: The Senior Associate, Cell Therapy Manufacturing will be responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements. Position Scope: 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.

Requirements

• Bachelor's or higher degree (Life Sciences or related field) or equivalent with 2 - 4+ years of experience working in a cGMP environment in the biotech or pharmaceutical industry.
• Biotechnology certificate with 4 - 6+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry or GED or equivalent with 8-10+ years of cGMP experience.
• Excellent communication skills, written and verbal.
• Experience with Microsoft Office suite.
• Ability to sit for long periods of time while performing physical duties.
• Ability to lift, carry, push and pull up to 50 lbs.
• Ability to work one weekend day and rotating holiday coverage.
• Ability to gown and gain entry to manufacturing areas.

Nice To Haves

• Experience in small scale tissue culture processing preferred.
• Experience working within a regulated environment that is frequently audited by internal and external Agencies, such as the FDA and ISO preferred.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 251-500 employees