Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.

Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio’s platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.

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.

Responsibilities:

●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.

Experience:

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

Skills:

●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.

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The anticipated annual salary range for this U.S. based job is $75,000– $100,000. The final offer will be based on professional experience previously in this role/industry, education, geographic location, internal equity, and other job-related factors as permitted by law. For remote-based candidates, this range may vary based on your local market. Actual compensation may vary. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, vision, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Total compensation will be determined at the Company's sole discretion. 

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 patients who need them.

We strive to do things right, and to embody our core values of passion, courage, and integrity. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate daily on a path that hasn’t been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren’t afraid to ask “why not,” and encourage lively discourse around rethinking the status quo.

We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.

We’re proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.

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 department, and all candidates are presented through this channel only. We do not accept unsolicited resumes.