Process Development Scientist/Engineer, CMC
Menlo Park, CA, USA
Posted on Monday, September 25, 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.
The Process Development Associate will focus on the development and optimization of allogeneic cell therapy manufacturing processes. You will contribute to process design, process optimization, scale-up/scale-out, and technology transfer into GMP manufacturing to advance Orca’s clinical pipeline from first-in-human through commercialization. This role is expected to closely collaborate with multiple teams across Process Development, Analytical Development, Regulatory Affairs, Quality and Manufacturing.
Roles & Responsibilities
- Design, optimize and implement process improvements related to closed and single-use cell therapy manufacture
- Optimize unit operations to maximize cell recovery and quality attributes
- Collaborate with external vendors and internal engineering teams to design and implement novel automation and closed processing technologies for cell therapy production
- Coordinate implementation of process improvements and new process technology into clinical and commercial GMP facilities
- Support technology transfer of processes into GMP clinical and commercial manufacturing, including on-floor support as Person-In-Plant and authoring of technical documents
- Design experiments and perform data analysis using DOE methodology
- Review and support continuous improvements of records and SOPs
- Maintain detailed records of experiments and outcomes
- Instrument set-up and preparation, maintenance, troubleshooting, and operation
- Bachelor’s degree in Chemical Engineering, Biotechnology, or related field
- 2 - 4 years of experience in process sciences or manufacturing
- Experience with aseptic techniques
- Experience with single use systems for cell washing and magnetic bead separations (MACS) preferred
- Experience with flow cytometry for analysis of cell populations preferred
- Willingness to work in a BSL-2 environment
- The role is based in our Menlo Park research labs, but occasional travel to our Sacramento facilities may be required
- Demonstrated organizational, record-keeping, and problem-solving skills, with an attention to detail
- Strong interpersonal skills including verbal and written communication
- Demonstrated success working independently as well as in a team environment
- Ability to act with urgency and agility to bring lifesaving therapies to patients
- Intense curiosity and a propensity to break with the status quo
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.