Cell Culture Manufacturing Supervisor
Cell Culture Manufacturing Supervisor— Los Angeles, CA
We are seeking a highly effective Manufacturing Supervisor to lead a team of cell culture manufacturing specialists in a commercial pharmaceutical cGMP environment with a leading company focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies.
Essential Duties and Responsibilities:
- Supervise operations of our commercial cell therapy manufacturing facility in a cGMP environment
- Build a team, provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews
- Generate SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacture
- Execute production and resource schedule against operational plan
- Ensure performance of all process steps specific to the phase or stage of operation
- Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements
- Review of completed manufacturing documentation per compliance standards and established timelines
- Investigate and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management
- Interact with outside vendors and senior management
- Participate in multi-functional project teams, as necessary
- Take corrective action to bring about required changes using change control procedures
- Other duties as assigned
- Bachelor’s or Master's degree in biology or related field (or equivalent experience required) with 5+ years of experience supervising staff
- Knowledgeable on current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's)
- Sufficient understanding of process, systems and equipment to troubleshoot problems and provide solutions to senior management
- Previous cell culture experience and/or experience with T cell receptor (TCR) engineered cell therapies
- Able to build and lead a team as well as train entry-level personnel
- Experience in a fast-paced commercial pharmaceutical cGMP environment preferred
- Knowledge of electronic quality systems and experience with Quality documentation.
- Willingness to think outside of the box and adapt best practices to our small, but growing environment
- Self-motivated with a strong sense of ownership in areas of responsibility
Apply Today! Questions? Call Justin at 714-602-1217 or send your resume to [Click Here to Email Your Resumé]
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