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.
Day Shift:• 6:00am to 6:30pm
or• 6:30am to 7:00pm
Work Week Schedule:• Sunday, Monday, Tuesday + every other Wednesday
or• Thursday, Friday, Saturday + every other Wednesday
Physical Demands- Production Associate Roles: 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.
- Most roles 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- Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.
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
$70,000 - $100,000 a year
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.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
