Orca Bio
Supervisor, Clinical Manufacturing, 2nd Shift
Sacramento, CA · Full-time
Sponsorship not specified$75k-$100kDetected 71 days ago
GMPLeadershipProblem SolvingMentoring
About the role
- More than one million people in the United States today are fighting blood cancer.
- 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 site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
Responsibilities
- 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 commercial-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.
- 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.
- Supervise and lead a team of associates, cell therapy production, oncology during assigned
Requirements
- 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
- 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 comfortable regularly participating in video-based meetings.
- May be required to work scheduled overtime, weekends, or holidays based on business needs.
Nice to have
- 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
Compensation
- 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.
Company info
- 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.
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This listing is sourced directly from Orca Bio's careers page and normalized into a canonical job model.