Associate Director, Manufacturing Sciences & Technology (MSAT)

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Orca Bio seeks an Associate Director, MSAT to lead the Global Projects team, guiding transfer of manufacturing processes from development to commercial operations at their Sacramento site. You will partner with Development, Quality, Operations, Regulatory, and CMC to scale and optimize high-precision cell therapies, drive PPQ and CPV activities, manage complex MSAT programs, and mentor engineers. Required: B.S. in Engineering, Chemistry, Biology or related field; 7–10 years in GMP manufacturing with proven project leadership, process optimization, automation, and risk management; experience with biologics or drug substance manufacturing; strong communication. Preferred: MS or PhD and 2–4 years of leadership; cell therapy experience. How to apply: tailor your resume to quantify impact on transfer, optimization, and compliance; prepare concise examples of cross-site project governance and data driven decisions; highlight CPV processes, CPPs, and regulatory alignment. Be ready for onsite Sacramento, embrace collaboration and a startup culture.

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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.

Physical Demands

• 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.

Work Conditions

• 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.

Essential Duties & Key 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

Minimum Qualifications:

• 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

Preferred Qualifications:

• 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

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. 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.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
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.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.