Supervisor, Clinical Manufacturing, 2nd Shift

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 vs. 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. 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 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 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.

• 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.

• 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.

• 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

• 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
• 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 
• 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 

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.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

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.

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.