Orca Bio
Biotechnology
Supervisor,CommercialManufacturing-DayShift
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“Supervisor, Commercial Manufacturing - Day Shift at Orca Bio. Skills: Cell therapy production, cGMP compliance, Team supervision. Supervise and lead associates. Coordinate daily manufacturing activities”
What You'll Achieve.
Meet schedule goals; Meet quality goals; Meet compliance goals; Increase reliability; Increase efficiency
Industry & Context.
Troubleshoot production activities
Visual acuity 20/20, Normal color vision, Cleanroom gowning, Work at multiple locations, Scheduled overtime, Work weekends, Work holidays, Remain stationary 50%
What They're Looking For.
Must Have
B. S. degree in biology, 2+ years supervisory experience, Understanding of aseptic manufacturing, Clean room operations knowledge
Nice to Have
M. S. degree in biology, Prior cell therapy experience, Experience with deviation investigations, CAPA experience, Change control process experience
What You'll Do.
Supervise and lead associates
Coordinate daily manufacturing activities
Execute and enforce cGMP-compliant SOPs
Provide on-the-floor training
Provide performance feedback
Monitor production activities
Troubleshoot production activities
Escalate production issues
Support in-process checks
Support deviation investigations
Support batch record reviews
Maintain real-time documentation
Support continuous improvement initiatives
Participate in CAPA investigations
Participate in deviation investigations
How You'll Work.
Team & Collaboration
Cross-functional teams
Full Job Description
## Description 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 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
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