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Orca Bio

Posted 12 months ago

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Supervisor, Commercial Manufacturing - Night Shift

SacramentoOn-siteFull-time

AI Summary

Supervisor overseeing a team of cell-therapy production associates on the night shift, ensuring compliant manufacturing, training, and issue resolution in a GMP cleanroom environment.

About this role

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.
Night Shift:
• 6:00pm to 6:30am or
• 6:30pm to 7:00am
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 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

  • Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

    • 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 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

    • Minimum 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

    • Preferred Qualifications

  • 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

    • Personal Qualities & Physical Demands

  • 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

    • Skills

    Aseptic ManufacturingBatch RecordsBatch ReleaseBioreactor/production EquipmentBiorisk ManagementBiosafety CabinetsCAPACell Therapy ProductionCGMP Compliant ProcessesChange ControlCleanroom OperationsDeviation InvestigationsDocumentationEquipment TroubleshootingGMPGowning ProceduresQA/QC CollaborationQuality SystemsRisk AssessmentSOPsToollists

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