More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease. 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.
We operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high‑precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
This is a 2nd shift‑based position, working on‑site Monday through Friday, from 3 pm 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.
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‑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.
- May be required to work scheduled overtime, weekends, or holidays based on business needs.
- 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.
- Must be comfortable regularly participating in video‑based meetings.
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.
- M.S. degree in biology or related field (preferred).
- Prior experience in cell therapy or other advanced biologics.
- Familiarity with deviation investigations, CAPAs and change control processes.
- Ability to gown and work in clean rooms and Biosafety safety cabinets.
- Ability to meet cleanroom gowning requirements, including wearing full gowning, face coverings, gloves, hoods, goggles.
- Strong interpersonal skills and ability to communicate effectively.
- Strong problem‑solving skills.
- Highly detail oriented with special attention to quality.
- Demonstrates strong work ethic, curiosity to learn and contribute in a fast‑paced collaborative environment.
- Ability to work independently and as part of a team.
- Ability to work in a collaborative manner.
- Highly tolerant and respectful of all team members.
- A sense of humor is always appreciated.
- Must be able to meet visual acuity of 20/20 (corrected or uncorrected) and normal color vision.
- Must be able to meet cleanroom gowning requirements, including no cosmetics, jewelry, facial piercings, or skin conditions that cause shedding.
- Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
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. 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.
EEO Statement
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
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