Manufacturing Excellence/Continuous Improvement Lead
Menlo Park, CA, USA
Posted on Saturday, September 9, 2023
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.
As we continue to scale our organization and expand our footprint, we’re seeking a Leader of Continuous Improvement/Manufacturing Excellence. In this role, you will drive implementation of new manufacturing technologies, and you will find and implement projects to improve the efficiency and effectiveness of our manufacturing operations.
- Drive implementation of new manufacturing technologies by developing effective implementation plans; own and lead activities as needed to ensure successful launch, and manage the change process end to end.
- Manage work products and coach/mentor/facilitate as needed, collaborating with cross functional teams.
- Autonomy to take personal responsibility for completing deliverables as needed. Depending on available expertise for each project, may need to generate and review documents, e.g. SOPs, CMC, IND, experiment design/protocols, etc.
- Have sufficient technical knowledge in general technology development, CMC content, change control and validation to be able to independently create and oversee implementation plans.
- Independently initiate projects to improve efficiency and effectiveness of manufacturing operations.
- Implement industry standard operational excellent tools as appropriate for each situation to gather relevant data, plan projects and ensure timely completion and effectiveness of projects.
- Establish and maintain performance metrics to measure and drive program success.
- Drive a culture of continuous improvement in the facility using operational excellent tools and processes.
- Expected to be on-site at our Sacramento, CA manufacturing facility as needed to implement projects.
- Bachelor’s degree in biology, chemistry, engineering or other relevant disciplines such as business management or organizational effectiveness.
- Demonstrated track record of successful implementation of manufacturing and business processes in pharmaceutical manufacturing.
- Understanding of and adherence to current Good Manufacturing Practices (cGMP) and FDA regulatory requirements.
- Experience in coaching, developing and influencing people and various levels in an organization.
- Strong consultation, project management and relationship building skills, and a proven track record of leading diverse cross-functional teams.
- Experience in Lean tools to drive continuous improvement, and comfortable training others in Lean.
- Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
- Strong oral, written, and listening skills, and a passion for efficiency.
- Ten (10)+ years’ related experience in the pharmaceutical/biotech industry, with increasing responsibilities.
- Prior experience in MSAT/manufacturing excellence.
- Advanced knowledge of flow cytometry.
- Cell therapy experience.
- Advanced knowledge of scientific/technical concepts.
- Background in chemical, mechanical or bio-engineering.
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.