Lead, Cell Therapy Manufacturing

Lead, Cell Therapy Manufacturing

POSITION SUMMARY

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality Assurance professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Senior Manager, Quality Operations at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

Under Manufacturing management guidance, the Manufacturing Team Lead I or II is responsible for oversight of manufacturing activities in the cleanroom for cell therapy products meeting internal and regulatory requirements.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Perform aseptic manufacturing procedures inside an ISO Class 7 cleanroom in accordance to established SOPs, cGMPs, and Safety regulations.
• Maintain frequent communication with Supervisor to exchange information, recommendations and to review daily cleanroom activities.
• Under Management guidance, provide consistent, ethical and responsible leadership to manufacturing teams to meet production demands.
• Provide guidance to staff consistent with cGMP and corporate quality governance.
• Serve as a liaison between employees and Management.
• Observe for process consistency within the team and report any observations to Management when problems occur. Receive guidance from Management regarding remediation.
• Serve as a technical resource for questions and/or investigate manufacturing issues.

Additional Responsibilities:

• Serve as a Qualified Trainer and assist with staff training.
• Assist Management with monitoring the staff and workload to meet or exceed productivity performance standards.
• Recommend ideas for improvement in work practices.
• Assist technicians with EBR issues and provide technical guidance.
• May provide input for the development of manufacturing policies (including operational, safety and quality programs).
• Perform tasks in Manufacturing software systems (e.g., sales order entries, confirming Preactor inventory and setting schedules including changes, GP entry and verification of process work, etc.).
• May learn the Preactor scheduling system and function as a backup Scheduler.
• May assist Management with coaching and mentoring of staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.
• Assist Management by offering feedback for annual performance reviews and provide ongoing input based on established goals.
• Perform activities within TeamShare (e.g., workflows, periodic reviews, etc.),
• Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as a role model for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Biotechnology Certificate with 2+ years of experience (Lead I) or 4+ years of experience (Lead II) working in a cGMP environment in the biotech or pharmaceutical industry.
• Must possess solid working knowledge of MS Office (Word/Excel/PowerPoint).

Preferred Qualifications:

• Bachelor’s Degree (Life Sciences or related field) or equivalent
• Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.
• Qualified as an On the Job Trainer.
• Excellent communication skills, written and verbal.

WORKING CONDITIONS AND 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.
• Rotating holiday coverage.
• Ability to gown and gain entry to manufacturing areas

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