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)
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, 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
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/or 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.
Skills Required
- Bachelor's degree in a science related field
- 2-3 years of experience in GMP Manufacturing, process sciences, or discovery
- Experience with aseptic techniques
- Familiarity with cell/gene therapy and working with human cells
What We Do
Orca Bio is a clinical-stage biotechnology company developing a pipeline of high precision allogeneic cell therapy products that are designed to safely replace patients’ diseased blood and immune system with a healthy one. Our manufacturing platform sorts donor blood with single-cell precision and a high level of purity and speed, enabling us to create proprietary, optimal therapeutic mixtures of immune and stem cells that have the potential to transform allogeneic cell therapy. Our talented team is driven by a passion for science and compassion for patients.
