Manufacturing Process Lead (2nd/3rd Shift)
About The Position
Orca Bio is a late-stage biotechnology company focused on developing next-generation cell therapies to redefine the transplant process for blood cancer patients. The company aims to provide significantly better survival rates with dramatically fewer risks compared to traditional allogeneic stem cell transplants. Orca Bio is establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of its high-precision cell therapy products. The Manufacturing Process Lead will conduct cGMP manufacturing activities for clinical and commercial cell therapies, optimize manufacturing processes, and ensure adherence to quality standards, regulatory requirements, and aseptic production techniques. This role involves executing manufacturing processes, maintaining equipment, documenting activities, and providing on-shift oversight to ensure efficient and quality-driven execution of daily objectives.
Requirements
- Bachelor’s degree in a science related field (Biology, engineering, etc.) or related field, required.
- 2-3 years of experience in GMP Manufacturing, process sciences, or discovery
- Experience with aseptic techniques
- Familiarity with cell/or gene therapy, including working with human cells, cell characterization methods, or cell separation techniques
- Flexibility to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs.
- Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision
- Ability to meet cleanroom gowning requirements, including wearing full gowning for extended periods
- Must disclose any skin conditions that cause shedding
Nice To Haves
- Master’s degree preferred
- Direct or indirect people leadership preferred
Responsibilities
- Oversee execution of routine manufacturing and occasional scientific protocols
- Develop and refine procedures for cell separation technologies, sterile connections, and aseptic techniques
- Serve as subject matter expert for cell therapy processes and new technology
- Provide verification for results and ensure detailed records are maintained
- Prepare, maintain, trouble-shoot, and operate instruments
- Plan the shift - including break management, shift pass downs, and process appropriate decisions
- Supervise in-room operations and delegate individual tasks based on operator capacity
- Complete deviations
- Escalate issues appropriately
- Review and support continuous improvements of business processes, records, and SOPs
- Training and coaching employees
Benefits
- pre-IPO equity
- annual bonus
- competitive medical, dental, and vision benefits
- PTO
- 401(k) plan
- life and accidental death and disability coverage
- parental leave benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
