Manager, Commercial Manufacturing

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. 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 Thursday, Friday, Saturday + every other Wednesday Physical Demands Production Associate Roles: 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. Most roles 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 Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video‑based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs. Essential Duties & Key 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. Minimum Qualifications 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. Preferred Qualifications 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. Salary Range $100,000 - $135,000 a year 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. #J-18808-Ljbffr Orca Bio