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Manufacturing Process Lead

Job in Princeton, Mercer County, New Jersey, 08543, USA
Listing for: Orca Bio
Full Time position
Listed on 2026-06-24
Job specializations:
  • Manufacturing / Production
    Pharmaceutical Manufacturing, Production QC/QA, Manufacturing Production
Salary/Wage Range or Industry Benchmark: 70000 - 90000 USD Yearly USD 70000.00 90000.00 YEAR
Job Description & How to Apply Below

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, documenting production activities in a highly regulated environment and providing on‑shift oversight of production activities to ensure timely, efficient, and quality‑driven execution of daily objectives.

This is a shift‑based position, Monday–Friday, day shift (1st shift).

Essential Duties &

Key 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, troubleshoot, 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
Minimum Qualifications
  • Bachelor’s degree in a science‑related field (Biology, engineering, etc.) or related field, required. Master’s degree preferred.
  • 2–3 years of experience in GMP manufacturing, process sciences, or discovery.
  • Experience with aseptic techniques.
  • Familiarity with cell/gene therapy, including working with human cells, cell characterization methods, or cell separation techniques.
  • Direct or indirect people leadership preferred.
  • Flexibility to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs.
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.
Salary & Benefits

$70,000 - $90,000 a year

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. For remote‑based positions, this range may vary based on your local market. Full‑time employment positions will also be eligible to receive pre‑IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.

Equal

Opportunity Employer

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.

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