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 Senior Facility Manager is responsible for overseeing and maintaining the physical tenant infrastructure, operating and maintaining all utility systems, managing service providers, maintaining GMP and safety compliance, and serving as the liaison with the building landlord. The Senior Facility Manager works closely with other departments to support the overall goals of the organization.

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.

Facility Operations & Maintenance:

Oversee the day-to-day operations and maintenance of the facility, ensuring all systems are functioning properly (HVAC, chilled water, heating hot water, clean dry air, electrical distribution, emergency generator, uninterruptible power, RODI water, domestic water systems, etc)
Manage service provider relationships (cleaning, pest control, security, maintenance and technical support services, etc.), ensuring delivery of quality services and compliance with service agreements.
Develop, implement and manage preventive maintenance and calibration programs to ensure the facility is GMP compliant.
Collaborate with Facilities and Production Planning to schedule and coordinate repairs and maintenance activities for building systems and equipment.
Ensure accurate record-keeping for facility operations, and equipment maintenance, including Computerize Maintenance Management System (CMMS) and logbooks.
Analyze, troubleshoot, and resolve system/equipment performance, malfunctions, or failures
Track and report on system/equipment downtime, failure trends and develop corrective actions to prevent recurrence
Coordination and execution of onsite and preventative and corrective maintenance, calibration and certification activities completed by service providers
Review and approval of service provider documentation, and completion and closeout of tasks in the CMMS

Health, Safety & Compliance:

Ensure the facility complies with all relevant safety, environmental, and regulatory requirements (e.g., OSHA, GMP, FDA, local building codes).

Participate in regular inspections to identify and mitigate risks related to safety, health, and environmental impacts.

Budget Management:

Support development and management of the facility’s operational and maintenance budget, controlling costs related to maintenance, repairs and outside services.

Project Management:

Plan and coordinate facility-related projects such as improvements or expansions.

Manage projects related to the installation of new equipment.

Work with other departments and external contractors and vendors to ensure successful project execution.

Education:

Bachelor’s degree in Facility Management, Engineering, or related field preferred, or equivalent job experience.

Experience:

7-10 years of experience in facility operations and management in a GMP environment, preferably in the cell therapy, biotechnology or pharmaceutical industry.

Skills:

Strong knowledge of building systems operations (HVAC, RODI, compressed air, domestic water, electrical), maintenance and calibration programs, GMP regulatory standards, and safety requirements in the biopharmaceutical/cell therapy industry.

Excellent leadership, communication, and interpersonal skills.

Experience/proficiency with maintenance management software and systems.

Excellent project and time management skills with the ability to oversee multiple tasks at once.

Budgeting experience.

Problem-solving and troubleshooting, and ability to make sound decisions.

Working Conditions:

The position requires on-site presence and regular work hours but may require on-call availability and after-hours presence for planned or unplanned work, or emergency response.

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.