Supervisor, Commercial Manufacturing - Night Shift

Physical Demands & Work Conditions

• Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
• Must be comfortable regularly participating in video-based meetings.

Key Responsibilities

• Supervise and lead a team of associates, cell therapy production, oncology during assigned shift operations.
• Coordinate daily manufacturing activities to meet schedule, and quality and compliance goals.
• Execute and enforce cGMP-compliant SOPs, batch records, and safety procedures
• Provide on-the-floor training, mentorship, and performance feedback to production staff
• Monitor and troubleshoot production activities and equipment, escalating as needed
• Partner with QA and QC to support in-process checks, deviation investigations, and batch record reviews
• Maintain real-time, accurate documentation of manufacturing processes and equipment use
• Support continuous improvement initiatives to increase reliability and efficiency.
• Participate in CAPA and deviation investigations related to manufacturing activities

Minimum Qualifications

• B.S. degree required in biology or related field
• 2+ years of supervisory or team experience is required
• Strong understanding of aseptic manufacturing practices and clean room operations

Preferred Qualifications

• M.S. degree in biology or related field
• Prior experience in cell therapy or other advanced biologics
• Familiarity with deviation investigations, CAPAs and change control processes

Personal Qualities & Physical Demands

• Ability to gown and work in clean rooms and Biosafety safety cabinets
• Highly detail oriented with special attention to quality
• Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
• Strong interpersonal skills and ability to communicate effectively
• Ability to work in a collaborative manner
• Ability to work independently and as part of a team
• Highly tolerant and respectful of all team members
• A sense of humor is always appreciated
• Strong problem-solving skills
• Must be able to remain in a stationary position 50% of the time while in a biosafety cabinet/cleanroom environment which includes wearing a PPE gown
• Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition
• Occasional need to ascend/descend stairs within workspace; job requires standing/walking