General manager, commercial manufacturing facility

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 commercial-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 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.

Summary of Position:

the General Manager/Site Head, Commercial Manufacturing will have overall leadership responsibility for our 200+ employee Sacramento manufacturing site and serve as the senior leader accountable for site performance, manufacturing execution, people, financial performance, quality and compliance, and long-term growth. This leader will lead and further develop a high-performing commercial manufacturing organization focused on reliable execution, operational efficiency, continuous improvement and the consistent delivery of high-quality, patient-critical cell therapy products.

Reporting to the Chief Quality Officer/EVP Manufacturing, the General Manager will work closely with Orca Bio’s executive leadership team to strengthen the site’s operating model, organizational capabilities, culture and systems as the facility continues to scale. This is a highly visible role for a strategic business leader, organizational builder and hands-on operator who brings a strong sense of urgency and stays close to day-to-day operations.

Location:

candidate must live and work full-time in Sacramento.

Physical Demands & Work Conditions

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. 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.

Responsibilities

Site Leadership & General Management

• Serve as the senior leader and overall business operator for the Sacramento commercial manufacturing site.
• Establish site priorities, governance, operating rhythms and performance objectives aligned with Orca Bio’s business goals.
• Lead the site leadership team and create clear accountability, fast decision-making and strong cross-functional execution.
• Build the organization, systems and capabilities required to support continued commercial growth.
• Provide executive leadership with clear visibility into site performance, risks, opportunities and resource needs.

Manufacturing & Operational Performance

• Lead commercial GMP manufacturing operations and ensure reliable delivery of patient-critical products.
• Drive improvements in throughput, productivity, cycle time, schedule adherence and right-first-time performance.
• Establish meaningful site KPIs and use data to identify bottlenecks, solve problems and improve performance.
• Bring a strong sense of urgency and a creative, pragmatic mindset to simplifying processes and improving how work gets done.
• Maintain strong quality, safety and compliance standards while enabling efficient, responsive operations.
• Lead production ramp-up, capacity expansion and operational scaling.

People & Organization Leadership

• Build, develop and retain a high-performing site leadership team and organization.
• Create a culture of ownership, accountability, collaboration and continuous improvement.
• Be a visible, hands-on leader who stays close to frontline operations and actively engages employees in solving problems.
• Develop leadership capability and succession plans for critical roles.
• Partner with Human Resources on workforce planning, organizational design and employee engagement.

Financial & Business Management

• Partner with Finance and executive leadership on budgets, headcount, capital requirements and long-range plans.
• Manage site resources against business priorities and commercial demand.
• Drive productivity and cost efficiency while protecting product quality and patient supply.
• Ensure the site has the workforce, equipment, systems and infrastructure required for future growth.

Qualifications

• Bachelor’s degree in engineering, life sciences, business, operations or a related discipline; advanced degree preferred.
• 15+ years of progressive leadership experience in biotechnology, pharmaceuticals or another highly regulated manufacturing environment.
• Significant senior leadership experience overseeing GMP manufacturing operations.
• Demonstrated experience as a Site Head, General Manager, Plant Manager or equivalent leader with broad accountability for a manufacturing operation.
• Proven experience ramping production, scaling operations and leading organizations through significant growth or change.
• Track record of improving manufacturing performance, efficiency, reliability and operational discipline.
• Experience leading large, cross-functional organizations and building strong leadership teams.
• Strong business, financial and operational acumen, with a practical understanding of cGMP requirements.
• Demonstrated ability to operate with urgency, make sound risk-based decisions and challenge established ways of working.
• Excellent executive communication and leadership skills.
• Experience in commercial biologics, cell therapy, gene therapy, pharmaceuticals, radiopharmaceuticals or another complex GMP manufacturing environment.
• Experience in a fast-paced manufacturing environment requiring flexibility and rapid execution.
• Experience with production ramp-up, commercialization or significant capacity expansion.
• Experience improving or transforming the performance of an established manufacturing site.

$275,000 - $350,000 a year

The anticipated annual salary range (listed above) 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. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, 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.