Manufacturing Process Lead (2nd/3rd Shift)

Orca Bio•Princeton, NJ

4d•$70,000 - $90,000•Onsite

About The Position

Orca Bio is a late-stage biotechnology company focused on developing next-generation cell therapies to improve survival rates and reduce risks associated with blood cancer treatments. They are establishing manufacturing operations on the East Coast to ensure the consistent delivery of their products. The Manufacturing Process Lead will conduct cGMP manufacturing activities, optimize processes, and ensure adherence to quality standards and regulatory requirements. 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
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
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.

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