Manager, 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.

Summary:  Located at our new commercial manufacturing facility at 7910 Metro Air Parkway, Sacramento, CA, the Manager, MSAT is responsible for leading the new Manufacturing Science and Technology team within the organization. This role oversees the optimization and continuous improvement of manufacturing processes and technologies to ensure product quality, efficiency and compliance with regulatory standards.

Responsibilities

• Lead a small team of scientists, engineers and technical experts
• Provide leadership and guidance in technical decision-making related to manufacturing operations
• Implement process improvements based on data analysis and scientific principles
• Lead efforts in production excellence to support commercial scalability and compliance
• Support the transfer of processes from R&D into GMP manufacturing facilities
• Collaborate with cross functional teams to trouble shoot and resolve technical issues

Required Education & Experience

• B.S. in Engineering, Chemistry, Pharmacy or related scientific discipline required
• PhD in Chemical Engineering, Biochemistry or Analytical Chemistry strongly preferred
• 6+ years of industry experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries
• 3+ years of people leadership experience
• Experience in Cell therapy manufacturing preferred
• Prior experience in regulated, GMP manufacturing operations
• Strong communication and problem-solving skills

Other Requirements

• Highly detail oriented with special attention to quality, compliance and safety
• Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
• Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
• Strong interpersonal skills and ability to communicate effectively
• Ability to work in a collegial and collaborative manner, independently and part of a team
• Ability to work in a fast-paced start-up environment while following SOPs
• Highly tolerant and respectful of all team members
• A sense of humor is always appreciated
• Strong problem-solving skills with desire to improve upon established processes
• Ability to work in cleanroom environments and, at times, across various shifts
• Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition
• Occasional need to ascend/descend stairs within workspace; job requires standing/walking