Orca Bio

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, fast-paced and growing biotechnology company supporting our manufacturing site(s) in Sacramento.

Responsibilities:

• Develop and implement facilities policies, SOPs and work instructions (WIs) for the asset management program, including the use of a GMP CMMS (computerized maintenance management system), preventative/corrective maintenance and calibration programs, and individual equipment/systems operations.
• Onboarding of new assets into a GMP CMMS, including the asset tagging.
• Maintenance of asset information in the asset management system.
• Coordination of service providers for onsite equipment/systems/building maintenance, repairs, certifications, and calibrations.
• Coordination of service providers for assets sent offsite for maintenance, repairs, and calibration.
• Oversight, review & approval of work activities completed by service providers.
• Coordination and completion of in-house preventative maintenance and repairs.
• Ensure that equipment and instruments are maintained and calibrated on time and to appropriate GMP standards.
• Ensure effective use of the asset management system, and identify and implement asset management system improvements.

Qualifications:

• Minimum of 4 years of experience in facilities and asset management, preferably in a GMP (Good Manufacturing Practice) environment.

Technical Skills:

• Experience implementing a CMMS, preferably in a GMP environment.
• Proficient in using a GMP CMMS for asset management.
• Experience in developing and implementing Standard Operating Procedures (SOPs), and programs related to asset management.
• Knowledge of preventative maintenance and calibration programs.
• Familiarity with tagging and onboarding processes for new assets in a GMP CMMS asset management system.

Maintenance and Coordination:

• Proven experience in coordinating onsite equipment/system/building maintenance, repairs, certifications, and calibrations.
• Ability to coordinate with service providers for offsite maintenance, repairs, and calibration activities.
• Demonstrated ability to implement new and revised preventative maintenance and calibration requirements.
• Ensure equipment and instruments are maintained and calibrated in accordance with GMP standards.

Other:

• 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 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 and ability to work in a collaborative team environment.
• Problem-solving skills and the ability to make sound decisions.

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, inquires and offers are managed through our HR/Talent department, and all candidates are presented through this channel only. We do not accept unsolicited resumes.