Sacramento Site Head, Biomanufacturing Operations

Orca-Bio; California; Presencial; USD 265.000 - 340.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Equity

Annual bonus

Health benefits

PTO

401(k)

Life insurance

Disability coverage

Parental leave

Lunch program

Descripción de la vacante

Orca Bio seeks a General Manager/Site Head for its Sacramento commercial manufacturing site. The role leads 200+ staff in a 24/7 operation, aligning governance, priorities and performance with Orca Bio’s growth strategy.

Reporting to senior leadership, you will drive manufacturing execution, quality and continuous improvement while building a scalable organization for future expansion and patient-supply reliability.

Formación

• Bachelor’s degree in engineering, life sciences, business, operations or related field.
• 15+ years of progressive leadership in commercial biologics, cell/gene therapy, pharmaceuticals, or radiopharmaceuticals.
• Senior leadership as Site Head/GM/Plant Manager with GMP operations responsibility.
• Proven track record improving manufacturing performance, efficiency and reliability.
• Experience leading large cross-functional teams with strong business acumen.
• Ability to make urgent risk-based decisions and drive capacity expansion.
• Experience with production ramp-up, commercialization and/or capacity expansion.

Responsabilidades

• Serve as senior leader and overall business operator for the Sacramento commercial manufacturing site.
• Establish and build upon site priorities, governance, operating rhythms and performance objectives.
• Lead the site leadership team with clear accountability, fast decision-making and cross-functional execution.
• Build the organization, systems and capabilities required to support continued commercial growth.
• Provide executive visibility into site performance, risks, opportunities and resource needs.
• 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 site KPIs and use data to identify bottlenecks and improve performance.
• Maintain strong quality, safety and compliance standards while enabling efficient operations.
• Lead production ramp-up, capacity expansion and operational scaling.

Conocimientos

Site leadership

Cross-functional leadership

GMP manufacturing

Educación

Bachelor’s degree in engineering

Advanced degree preferred

Descripción del empleo

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, 24/7 Sacramento manufacturing site, which has undergone significant recent expansion and continues to scale. This leader will serve as the senior site executive accountable for operational performance, manufacturing execution, people, financial performance, quality and compliance, and long-term growth.

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, culture and capabilities while driving reliable execution, operational efficiency and continuous improvement. This is a highly visible role for a strategic business leader 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; relocation support will be provided as needed.

Responsibilities

Site Leadership & General Management

• Serve as the senior leader and overall business operator for the Sacramento commercial manufacturing site.
• Establish and build upon 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 and build upon 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 commercial biologics, cell/gene therapy, pharmaceuticals, or radiopharmaceuticals.
• Significant senior leadership experience as a Site Head, General Manager, Plant Manager or equivalent, with broad accountability for GMP manufacturing operations.
• Demonstrated track record of improving manufacturing performance, efficiency, reliability and operational discipline.
• Experience leading large, cross-functional organizations and building high-performing 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.
• Experience with production ramp-up, commercialization and/or significant capacity expansion.

$265,000 - $340,000 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. 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.