Senior Associate, Cell Therapy Manufacturing

Role Summary

The Senior Associate, Cell Therapy Manufacturing will be responsible for the execution of process steps to manufacture commercial cell therapy products in compliance with internal and regulatory requirements. This role is in-office Wednesday–Saturday and split between the Burlington, MA facility and the Cambridge, MA location. The position involves performing manufacturing procedures in a clean room, documenting operations, and maintaining compliance with cGMPs and SOPs to support MACI and Epicel production.

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 (SOPs 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

• 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.
• 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.
• 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.