Manager, Commercial Manufacturing

Orca Bio • Sacramento, CA

28d • $100,000 - $135,000 • Onsite

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 Manager, Commercial Manufacturing oversees the daily operations within our GMP manufacturing facility. This individual will manage the production of cell-based therapies, ensuring adherence to regulatory guidelines, standard operating procedures (SOPs), and quality standards. The successful candidate will play a pivotal role in delivering patient batches with a high degree of safety, quality and reliability while mentoring and guiding a team of Supervisors and support Cell Therapy Production Associates, Oncology.
Work Week Schedule:
• Sunday, Monday, Tuesday + every other Wednesday or
• Thursday, Friday, Saturday + every other Wednesday

Requirements

• Bachelor's degree in a relevant field such as Biotechnology, Engineering, Manufacturing or Operations Management; advanced degree preferred.
• 3-5 years of experience in GMP cell therapy, biologics, or pharmaceutical manufacturing environment
• 2-4 years in a people leadership or supervisory role.
• Deep understanding of aseptic processing, closed system operations and cell therapy techniques.
• Excellent analytical, problem-solving, and decision-making skills.
• Organizational, interpersonal and communication skills.

Nice To Haves

• Masters or PhD in Chemical Engineering, Biochemistry or Biology is preferred
• 5+ years of leadership experience preferred
• Experience in Cell therapy manufacturing preferred
• Experience with regulatory inspections and cGMP compliance preferred.

Responsibilities

• People leadership: Supervise and manage manufacturing staff including supervisor and operators to ensure timely execution of production batches. Coach and develop talent and train team members on SOPs, aseptic techniques, and safety protocols.
• Execution of Manufacturing Activities: Responsible for coordinating production execution activities to meet production schedules and deliver products to quality standards, reliably and on time. Manage deviations, corrective and preventative actions and change controls and drive continuous improvements in manufacturing execution.
• Compliance & Quality Assurance: Ensure all manufacturing execution activities comply with industry standards and regulations (e.g., GMP, ISO). Work closely with the quality team to ensure that batch manufacturing meets product quality and safety requirements. Drive needed corrective and preventive actions.
• Continuous Improvement Culture: Foster a culture of continuous improvement within the organization, encouraging employees to contribute ideas, solve problems, and implement solutions that drive improvement in execution. Drive manufacturing improvements in communication, manufacturing flow and batch execution.
• Cross-Functional Collaboration: Work closely with MSAT, engineering, quality, and supply chain teams to drive daily activities and ensure execution to manufacturing schedules. Facilitate communication between teams to ensure execution to safety, quality and reliability of batch production.
• Employee Safety: Promotes a safety-first culture reinforcing a mindset of safety as integral to product quality and patient outcomes. Ensure employee compliance with safety regulations. Enforce the use of personal protective equipment (PPE), sterile gowning protocols, and ergonomic practices.
• May require shift, weekend, or holiday coverage to support manufacturing and patient treatment timelines.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager