Jobs at Vericel Corporation

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

• 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.
• Able to make cell-culture decisions based on cell observations and guidelines in written procedures.
• 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. Demonstrate the ability to organize, plan and manage time to effectively complete daily tasks. Be receptive to feedback and guidance from manager and other more experienced staff.
• Build and grow our teams through collaboration and positive interactions. The ability to cooperate with others in a team environment will be critical to your and our combined success.
• Practice safe work habits and adhere to Vericel’s safety procedures and guidelines.
• Assist in reviewing and revising production documents (SOP’s and electronic records).
• 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, D365 ERP, TrackWise, Veeva.

Basic 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 HS diploma/GED with 2+ years of cGMP experience.
• Excellent communication skills, written and verbal.
• Experience with Microsoft Office suite.

Preferred Qualifications:

• Biotechnology certificate that includes hands-on laboratory courses.
• Experience in small scale tissue culture processing.
• Experience working within a regulated environment that is frequently audited by internal and external Agencies, such as the FDA and ISO