Manufacturing Process Lead

Orcabiosystems; Princeton (NJ); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, and vision benefits

PTO

401(k) plan

Life and accidental death and disability coverage

Parental leave benefits

Job summary

Orcabiosystems in Princeton, NJ is looking for a Manufacturing Process Lead to manage cGMP manufacturing activities for clinical and commercial cell therapies. The role involves optimizing manufacturing processes, ensuring quality standards, and overseeing production activities.

The ideal candidate will have a science degree, GMP experience, and the ability to work with aseptic techniques. The position offers a comprehensive benefits package including pre-IPO equity and competitive medical plans.

Qualifications

• 2-3 years of experience in GMP Manufacturing or process sciences.
• Experience in cell separation techniques.
• Visual acuity and color vision necessary for tasks.

Responsibilities

• Oversee execution of manufacturing processes.
• Refine procedures for cell separation technologies.
• Train and coach employees.

Skills

GMP Manufacturing experience

Aseptic techniques

Cell therapy familiarity

Leadership experience

Education

Bachelor's degree in a science related field

Master's degree (preferred)

Job description

Overview

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. 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.

Position Summary

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.

This is a shift‑based position, Mon – Fri, day shift (1st shift).

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

Qualifications

• Bachelor’sdegree 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/or gene therapy, includingworking 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
• 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
• 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

Compensation & Benefits

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.

• 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

Equal Opportunity Statement

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.