Senior Associate, Cell Therapy Manufacturing

About the role

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.
• 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.
• Organize small groups and teams to deliver key initiatives and small projects.
• Use time management and collaboration across the team to seek out opportunities to ensure delivery of the Manufacturing Team’s daily tasks.
• Work with influence and rapport across the Team.
• Build and grow our teams through collaboration and positive interactions.
• Support the Team Leads by demonstrating influence and leadership qualities.
• Identify and report deviations, lead GEMBA interviews, and contribute to deviation investigations.
• Cross train and qualify in at least 5 core competencies including 3T3, Media Prep, D365 ERP, TrackWise, and Veeva.
• Achieve and maintain approved Qualified Trainer status for at least 3 Operations.
• Be receptive to feedback and coaching on training methods and support efforts to drive consistency and standardization on operational methodology.
• Serve as a technical resource for questions and/or investigate manufacturing issues.
• Collaborate with Production Planners to ensure schedule accuracy.
• Communicate patient lots status with Customer Care team.

Requirements

• Bachelor’s or higher degree (Life Sciences or related field) or equivalent with 3+ years of experience with Vericel operations with demonstrated behaviors associated with the role (Internal) or 4+ years of experience working in a cGMP environment in the biotech or pharmaceutical industry.
• HS Diploma/GED with 4+ years of experience with Vericel operations with demonstrated behaviors associated with the role (Internal) or with 5+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry.
• Excellent communication skills, written and verbal.
• Experience with Microsoft Office suite.

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.

Benefits

Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Pay

The hourly wage range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $35.00 to $37.00 per hour. The actual salary offered will be determined based on factors such as the candidate’s qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.