Process Development Scientist, CMC

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.

Summary:

Reporting to our Director of CMC, you will play a pivotal role in achieving process performance qualification (PPQ) and biologics license application (BLA) submission milestones. You will lead process characterization studies, conducting wet lab evaluations of key unit operations across the cell therapy process. You may support or lead other work related to process characterization/validation, such as stability studies. You will focus on ensuring cell viability, purity, and potency throughout the process. Note that while the role includes learning and execution of assays, it does not primarily focus on assay development, product characterization, or­ method validation. The ideal candidate will possess a strong scientific background, attention to detail, and adaptability to evolving priorities. Previous experience in process characterization/validation is advantageous.

Success Milestones:

Success in this role will be marked by significant contributions to PPQ and BLA processes, effective leadership in process characterization studies, and adherence to CMC timelines. Over a short period of time, the individual will gain invaluable expertise in late-stage process development. After achieving key milestones, the individual may potentially transition to new focus areas as business needs evolve.

Key Responsibilities:

· Lead process characterization and process validation experiments and wet lab evaluations.

· Ensure cell viability, purity, and potency throughout the process.

· Assist in data review for scientific integrity.

Required Qualifications:

· Experience in a lab environment, preferably in process development.

· Strong scientific principles and understanding of biologics/cells.

· Familiarity with process characterization/validation and regulatory requirements.

Preferred Qualifications:

· Experience with cell therapy processes and selection mechanisms.

· Previous exposure to late-stage process development and CMC.

· Regulatory compliance experience.

· Prior experience with MACS and/or FACS.

· PhD in Chemical Engineering, Immunology, Biochem., or a related scientific discipline.

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.