Associate Director, Manufacturing Sciences & Technology (MSAT)
About The Position
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.
Requirements
- B.S. in Engineering, Chemistry, Biology or related scientific discipline required
- 7 to 10 years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries
- Prior experience implementing projects in regulated, GMP manufacturing operations
- Strong communication and problem-solving skills
- Knowledge of automation, continuous process verification, investigation processes, process optimization
Nice To Haves
- Masters or PhD in Chemical Engineering, Biochemistry or Biology is preferred
- 2 to 4 years of leadership experience preferred
- Experience in Cell therapy manufacturing preferred
Responsibilities
- 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
Benefits
- You will also be eligible to receive pre-IPO equity, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.
- Other perks include subsidized daily lunches and snacks at our on-site locations.
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What This Job Offers
Job Type
Full-time
Career Level
Director
