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