Associate I, Cell Therapy Manufacturing

Key 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.
• 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).
• Able to identify and report deviations and contribute to deviation investigations.

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.

Working Conditions & Physical Demands

• May be required to sit for long periods of time while performing cell culture operations.
• Must be able to lift, carry, push and pull up to 50 lbs.
• Ability to work 1 weekend day per week.
• Rotating holiday coverage.
• Ability to gown and gain entry to manufacturing areas.