Supervisor, Clinical Manufacturing, 2nd Shift
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.
This is a 2nd shift-based position, working on-site Monday through Thursday, from 3pm 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 proceduresProvide on-the-floor training, mentorship, and performance feedback to production staffMonitor and troubleshoot production activities and equipment, escalating as neededPartner with QA and QC to support in-process checks, deviation investigations, and batch record reviewsMaintain real-time, accurate documentation of manufacturing processes and equipment useSupport continuous improvement initiatives to increase reliability and efficiency.Participate in CAPA and deviation investigations related to manufacturing activitiesMinimum Qualifications
B.S. degree required in biology or related field2+ years of supervisory or team experience is requiredStrong understanding of aseptic manufacturing practices and clean room operationsPreferred Qualifications
M.S. degree in biology or related fieldPrior experience in cell therapy or other advanced biologicsFamiliarity with deviation investigations, CAPAs and change control processesPersonal Qualities & Physical Demands
Ability to gown and work in clean rooms and Biosafety safety cabinetsHighly detail oriented with special attention to qualityDemonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environmentStrong interpersonal skills and ability to communicate effectivelyAbility to work in a collaborative mannerAbility to work independently and as part of a teamHighly tolerant and respectful of all team membersA sense of humor is always appreciatedStrong problem-solving skillsMust be able to remain in a stationary position 50% of the time while in a biosafety cabinet / cleanroom environment which includes wearing a PPE gownFollow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin conditionOccasional 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. You will also be eligible to receive pre-IPO equity, in addition to competitive medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations.