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.

Reporting into our Director of Facilities, this is an exciting opportunity to join a small, innovative, fast-paced and growing biotechnology company supporting our manufacturing site(s) in Sacramento.

●        Develop, implement, revise and execute Standard Operating Procedures (SOPs) and Work Instructions (WIs) for GMP facility and asset management programs, including a GMP Computerized Maintenance Management System (CMMS), and facility and equipment operation, maintenance and calibration programs.

●        Onboarding new assets and maintaining current assets in the CMMS, including asset identification and status tagging, and required maintenance and calibration plans.

●        Planning, scheduling and coordinating onsite and offsite maintenance and calibration activities to be completed by service providers or company personnel.

●        Review & approval of service provider documentation. 

●        Maintenance and calibration task completion and closeout in the CMMS.

●        Ensure that the facility and assets are maintained and calibrated to appropriate GMP standards.

●        Ensure effective use of the facility and asset management programs, including CMMS, personnel training, and identification and implementation of improvements.

●        Minimum of 4 years of experience in GMP facility and asset management. 

 

●        Experience using a GMP CMMS (Computerized Maintenance Management System) for asset management.

●        Experience implementing a CMMS, preferably in a GMP environment, is desired.

●        Experience in developing and implementing SOPs and WIs for GMP facility and asset management programs.

●        Demonstrated knowledge of facility and asset maintenance and calibration programs.

●        Experience in planning, scheduling and coordinating GMP facility and asset maintenance and calibration activities.

●        Effective communication and coordination skills to consult with internal teams and external service providers.

●        Proactive approach to identifying and implementing improvements in asset management systems and work processes.

●        Familiarity with industry best practices and a commitment to staying updated on emerging trends in facilities and asset management.

●        Detail-oriented with strong organizational skills.

●        Ability to work in a collaborative team environment.

●        Demonstrated problem-solving skills and ability to make sound decisions.

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.

To learn more: https://orcabio.com/join-our-team/

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.