Manufacturing Supervisor - United States
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- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- We are seeking a highly effective Manufacturing Supervisor to be responsible for supervising a team of cell culture manufacturing specialists in a commercial pharmaceutical environment. In this role you will report to the Manager of Manufacturing.
- Supervise the on-the-floor 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 degree in biology or related field (or equivalent experience required), 2 years of experience supervising staff
- Able to build and lead a team as well as train entry-level personnel
- Knowledgeable of the 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
- Sufficient knowledge of electronic quality systems
- Must be able to work on off shift hours as well as part of the on-call rotation as needed is required; weekend shift likely
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
- Willingness to think outside of the box and adapt best practices to our small, but growing environment
- Ability to adapt in a constantly evolving environment
- Self-motivated with a strong sense of ownership in areas of responsibility
- Previous cell culture experience preferred/highly desired
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.