Associate Director, Manufacturing Sciences & Technology; MSAT

Associate Director, Manufacturing Science and Technology (MSAT)

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 have built a state‑of‑the‑art, 100,000‑square‑foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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.

The Associate Director, Manufacturing Science and Technology (MSAT) is responsible for leading the Global Projects team under the Manufacturing Science and Technology department within the Orca organization. This role oversees manufacturing processes as they transfer from development into commercial operations and throughout the commercial lifecycle of the product. The Associate Director, MSAT works closely with teams, such as Development, Quality, Operations, Regulatory Affairs and Chemistry and Manufacturing Controls to launch, scale‑up and optimize operational attributes to ensure product quality, efficiency and compliance with regulatory standards.

• Production Associates:
  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.

• Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
• Must be comfortable regularly participating in video‑based meetings.
• May be required to work scheduled overtime, weekends, or holidays based on business needs.

• Lead a team of engineers and technical experts to support the launch, scale up and maintenance of late stage and commercial manufacturing processes
• Develop strategies to enhance manufacturing processes, including optimizing processes for investigation, corrective actions and change management for MSAT projects
• Act as Project Manager for complex technical projects; provide technical direction and governance to implement process improvements across multiple sites based on data analysis and scientific principles including focus on technology, alternate materials, shipping and labeling, and data from continuous process verification
• Drive the execution of various studies, qualifications and design of experiments related to new materials, process performance, and regulatory needs for commercial products.
• Coordinate with the operations team to ensure successful implementation of new processes or process improvements in clinical and commercial GMP environments
• Lead process performance qualification (PPQ) and continuous process verification (CPV) activities for commercial products
• Use risk management tools to drive reliable product quality and supply
  
  Independently assess the impact of changes to products, processes, equipment, procedures, or materials
• Build and mentor team members to ensure the team is equipped with the skills and tools to meet current and future manufacturing needs

• B.S. in Engineering, Chemistry, Biology or related scientific…