Supervisor, Clinical Manufacturing

ImmPACT-Bio is seeking a Supervisor, Clinical Manufacturing to be responsible for supervising a team of Cell Therapy Specialists in a Clinical Manufacturing environment. The candidate will supervise all activities related to the cGMP manufacturing of cell therapy products. The supervisor will also support facility commissioning and validation of the new GMP cell therapy production facility located in West Hills, CA. Candidates will have appropriate experience managing cGMP operations, scientific expertise and knowledge of the regulations governing the production of cell therapy as mandated by the United States Food and Drug Administration (FDA), European Medicines Agency (EMEA) and other guidelines as appropriate. The Supervisor of Clinical Manufacturing will work closely with Process Development, Quality Control, Quality Assurance and Project Management on all aspects of cGMP manufacturing. This full-time position reports to the Director of Manufacturing.

Primary Responsibilities:

• Supervise on-the-floor operations of our clinical cell therapy manufacturing facility in a cGMP environment
• Schedule personnel resources according to operational plan
• Build a team, provide necessary training on controlled, approved GMP procedures and ongoing coaching
• Document employee growth and performance
• Generate SOPs, MBRs, and Work instructions for equipment and procedures used in cell therapy manufacturing
• Execute production and resource schedule against operational plan
• Ensure performance of all process steps specific to the phase or stage of operation
• Review of completed manufacturing documentation in real time per compliance standards and established timelines
• Investigate and resolve problems (deviations), identifying root cause, and proposing process improvements through clear communication to senior management
• Work with the appropriate people from both the quality and operational organizations to develop corrective and preventive actions
• Take corrective action to bring about required changes using change control procedures
• Must be able to: Multitask, be flexible, handle high-pressure situations, have strict attention to detail, and work in a close-knit team-oriented atmosphere.
• Able to manage overlapping projects, keep track of deadlines, and efficiently use of time to meet deadlines.
• Must be able to fill in as need for management planning scenarios.
• Must have the confidence and ability to deal professionally with both internal and external customers.
• Ability to adjust to rapidly changing priorities and incorporate changes seamlessly.
• This role will require advanced levels of information sharing and interactions with all functional areas across the company, including Manufacturing, Facilities, Project Management, and Clinical sites.
• This is an onsite role that may require occasional off-shift support, including weekends.
• Other duties as assigned

Qualifications:

• High School Diploma or GED with at least six (6) years of experience, Bachelor of Science with two (2) years of experience, or Advanced Degree with zero (0) years of experience or equivalent amount of education and experience in a Clinical Manufacturing operation, manufacturing sciences, technology, or manufacturing technical support role.
• Cell therapy-based therapeutics such as CAR-T, or other cell-based products is a plus
• Demonstrated ability to follow established policies and procedures
• Previous cell culture experience
• 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), Current Good Manufacturing Practices (cGMP's) and Good Documentation Practices (GDP)
• Knowledge of electronic quality systems
• Provide and adapt best practices to our small and growing environment
• Ability to adapt in a constantly evolving environment
• Self-motivated with a strong sense of ownership in areas of responsibility
• Possess meticulous record-keeping skills, be highly organized, with strong attention to detail along with excellent communication and interpersonal skills
• Possess aseptic/sterile techniques including fill/finish and prior experience with biopharmaceutical manufacturing
• Experience with automated processing equipment
• Excellent skills in Microsoft Word, Excel and data analysis
• Ability to think critically, and demonstrate troubleshooting and problem-solving skills applicable to manufacturing process and equipment
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
• Willingness to think outside of the box, ability to adapt in a constantly evolving environment

Travel Requirements:

• Up to 15% travel
• Willingness to travel domestically and internationally for business meetings and conferences.