Associate I, Cell Therapy Manufacturing

Role Summary

The Associate I, Cell Therapy Manufacturing is responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.

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, cross train and qualify in at least one core competency e.g. 3T3, Media Prep, GP, TrackWise, Veeva.
• Achieve Qualified Trainer status.
• Other duties as assigned.

Qualifications

• Bachelor’s degree (Life Sciences or related field) with 0 - 2 years of experience working in a cGMP environment in the biotechnology/pharmaceutical industry or Biotechnology certificate with 1 – 2+ years of experience working in a cGMP environment in the biotechnology/pharmaceutical industry or HS diploma/GED with 4 - 6+ 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 cell culture operations.
• Ability to lift, carry, push and pull up to 50 lbs.
• Ability to work 1 weekend day and rotating holiday coverage.
• Ability to gown and gain entry to manufacturing areas.