Supervisor, Commercial Manufacturing - Day Shift
About The Position
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The Supervisor, Commercial Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to Associates, Cell Therapy Production, Oncology to ensure timely and compliant manufacturing.
Requirements
- 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
- 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.
- Ability to gown and work in clean rooms and Biosafety safety cabinets
- 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
Nice To Haves
- 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
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
Benefits
- competitive medical, dental, and vision benefits
- PTO
- 401(k) plan
- life and accidental death and disability coverage
- parental leave benefits
- subsidized daily lunches and snacks at our on-site locations
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
