Manufacturing Process Lead (2nd/3rd Shift)
On-sitePrinceton, New Jersey, United States
Job Summary
Oversee execution of routine manufacturing and occasional scientific protocols to produce clinical and commercial cell therapies while adhering to cGMP standards and aseptic techniques. Develop procedures for cell separation technologies, prepare and operate instruments, and supervise in-room operations by planning shifts, managing breaks, and delegating tasks based on capacity. Serve as subject matter expert for cell therapy processes, complete deviations, and support continuous improvements of business processes and SOPs. Provide verification for results, ensure detailed records are maintained, and train employees. This shift-based role requires flexibility to work outside standard business hours and includes on-shift oversight of production activities to ensure timely, efficient, and quality-driven execution.
Required Qualifications
- 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
- Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods
- Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom
- Any skin conditions that cause shedding must be disclosed
Desired Qualifications
- Master's degree preferred
- Direct or indirect people leadership preferred
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