Cell Therapy GMP Manufacturing Lead – 2nd/3rd Shift

Orca Bio; Princeton (NJ); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Pre-IPO equity

Medical insurance

Dental & Vision

PTO

401(k)

Parental leave

Job summary

Orca Bio is establishing East Coast manufacturing operations to deliver high-precision cell therapies. The Manufacturing Process Lead will oversee cGMP manufacturing activities for clinical and commercial products, ensuring quality, regulatory compliance, and efficient production.

This role includes on-shift oversight, equipment operation, and continuous process improvements. The ideal candidate has a science degree, 2–3 years GMP experience, aseptic technique proficiency, and leadership skills.

Qualifications

• Bachelor’s degree in a science-related field required; Master’s preferred.
• 2–3 years of GMP manufacturing, process sciences, or discovery experience.
• Experience with aseptic techniques in a regulated environment.
• Familiarity with cell/gene therapy and human cell handling.
• Direct or indirect people leadership preferred.

Responsibilities

• Oversee routine manufacturing and support scientific protocols.
• Develop procedures for cell separation, sterile connections, and aseptic techniques.
• Serve as subject matter expert for cell therapy processes and new technology.
• Verify results and maintain detailed records.
• Operate instruments and troubleshoot issues.
• Plan shifts, manage breaks and pass-downs, and supervise room operations.
• Address deviations and support continuous improvements of processes and SOPs.
• Train and coach employees.
• Escalate issues as needed.

Skills

GMP Manufacturing

Aseptic Techniques

Cell Therapy

Leadership

Documentation

Education

Bachelor’s degree in science or related field

Master’s degree preferred

Tools

Process equipment operation

Job description

Orca Bio is establishing East Coast manufacturing operations to deliver high-precision cell therapies. The Manufacturing Process Lead will oversee cGMP manufacturing activities for clinical and commercial products, ensuring quality, regulatory compliance, and efficient production.

This role includes on-shift oversight, equipment operation, and continuous process improvements. The ideal candidate has a science degree, 2–3 years GMP experience, aseptic technique proficiency, and leadership skills.