This is a 2nd shift-based position, working on-site Monday through Thursday, from 1pm to 11:30 pm. The
Supervisor, Clinical 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.
Physical Demands- 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 be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. 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.
Work Conditions- Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
- Must be comfortable regularly participating in video-based meetings.
- May be required to work scheduled overtime, weekends, or holidays based on business needs.
Essential Duties & 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
$75,000 - $100,000 a year
This position is eligible for shift-differential pay of +5%!
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
