Associate/Director, Facilities and EH&S
Orca Bio
Operations
Sacramento, CA, USA
Posted on Wednesday, September 21, 2022
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.
Orca Bio is a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases, and genetic blood disorders. Our investigational therapies are designed to deliver better survival rates with dramatically fewer risks than standard allogeneic stem cell transplants, like graft versus host disease and other debilitating transplant-related toxicities. At Orca Bio, we hope to not only replace patients' blood and immune systems with healthy ones but restore their quality of life.
As we continue to scale our organization and expand our footprint, we’re seeking a Facilities and EH&S leader to be accountable for ensuring our facilities and equipment are safe, functional and compliant.
Responsibilities
- Responsible for ensuring safe and compliant facility operations at Orca Bio’s production sites in Sacramento.
- Manage lab and building infrastructure functionality.
- Ensure that equipment and instruments are maintained and calibrated on time and to appropriate GMP standards.
- Accountable for all facilities-related SOPs, policy documents, and documents related to work order completion, vendor services, testing data, and equipment.
- Ensure effective use of the maintenance and asset management systems and drives improvements to the program as required.
- Responsible for overseeing the execution of small-to-midsize capital construction projects to upgrade or expand our Sacramento facilities and equipment. Makes sure that these projects are planned to effectively meet site needs and executed accordingly.
- Serve as the Facilities partner for mid-to-large scale capital construction projects.
- Provide strategic planning for all aspects of the Sacramento facilities, including future space requirements and providing stage-appropriate workspace solutions for our anticipated growth.
- Accountable for the Environmental, Health and Safety (EH&S) program for the sites in Sacramento.
- Ensures compliance of the site and site operations relative to applicable state and federal regulations, including OSHA and FDA.
- Maintains all EH&S records, including exposure monitoring and generate reports as required.
- Initiates, leads and implements EH&S improvement projects. Provides EHS guidance on facility’s maintenance and construction projects to minimize or eliminate adverse impacts.
- Expected to be the facilities, utilities and EH&S subject matter expert and first point of contact for facilities and EH&S questions related to audits and associated compliance.
- Provides leadership to peers and staff. Fosters open and honest communication. Promotes a collaborative culture where you lead by example.
Qualifications
- Bachelor's degree plus minimum of 10 years of Engineering/Facilities experience and 6+ years related experience in the biotech industry within a GMP manufacturing/operations function.
- Strong technical knowledge of manufacturing and QC lab needs, and knowledge of cGMP requirements as they relate to manufacturing and lab environments.
- Experience working with Federal, State and local agencies, including the fire department and OSHA to ensure compliance with local laws.
- Understanding of lab based EH&S disciplines. Experience managing hazardous waste and biowaste operation, biosafety, chemical safety and occupational safety
- Able to work in a fast-paced and dynamic environment with competing priorities; successfully drive projects forward to meet program/project deliverables
- Regularly seeks opportunities to improve existing processes and drive change that positively impacts organizational success
- Excellent and effective written, verbal communication and presentation skills.
- Must be able to work in a fast paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation.
- Operates with transparency. Excellent judgment and creative problem-solving skills.
Who we are
We are scientists, engineers and business operators working with urgency to develop new therapies for patients faced with no or extremely limited options today.
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. 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.
We invite you to join us and bring your unique perspective and experiences to our team.
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