- 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.
- 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.
- 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.
- 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).
- 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.
- 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
Lead, Cell Therapy Manufacturing - Cambridge, United States - Vericel® Corporation
Description
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:
Additional Responsibilities:
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Leadership Qualifications:
Basic Qualifications:
Preferred Qualifications:
WORKING CONDITIONS AND PHYSICAL DEMANDS