Manufacturing Process Lead

Orca Bio • Princeton, NJ

8d • $70,000 - $90,000 • Onsite

About The Position

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 are establishing manufacturing operations on the East Coast 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 Manufacturing Process Lead conducts cGMP manufacturing activities to produce clinical and commercial cell therapies and helps to optimize Manufacturing processes. The Lead ensures and adheres to quality standards, regulatory requirements and aseptic production techniques. This position involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. This position also entails on-shift oversight of production activities to ensure timely, efficient, and quality-driven execution of each day’s 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 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.

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
• Other duties as assigned

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level