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 the Head of CMC, you will play a pivotal role in supporting the development, qualification, transfer and validation of analytical methods focused on the potency assays for our cell-based products, which are purified from mobilized peripheral blood and are composed of hematopoietic stem and progenitor cells (HSPCs), regulatory T cells (Treg) and conventional T cells (Tcons).

Building on existing assays, you will work to finalize and generate the potency strategy with a matrix of technologies that characterize the biological products being developed in clinical trials. In addition, you will coordinate the transfer and validation of potency assays to our Quality Control (QC) team for late-stage development and commercialization. The ideal candidate will possess a strong scientific background, attention to detail, and adaptability to evolving priorities. Previous experience in the development of assays for cell based biological products is advantageous.

Success Milestones:

Success will be marked by significant contributions to the preparation of Biological License Application (BLA) and commercial readiness for our biological products. Over a short period of time, you will gain invaluable expertise in late-stage process development. 

Key Responsibilities:

• Supports multiple analytical method development and qualification of the potency assays to support the development of cell-based products composed of HSPCs and Tcells.
• Generates, compiles, and evaluates data for technical reports to support regulatory filings for the matrix of assays focused on the potency strategy.
• Responsible for writing appropriate sections of the assay’s method and standard operating procedures (SOPs).

• PhD in Immunology, Biochemistry, or a related scientific discipline plus a minimum of 3 years of industry experience.
• Experience in developing and qualifying in vitro cell-based assays to reflect the relevant mode of action for cell-based products.
• Experience in cell culture and state-of-the-art cell and molecular biology techniques.
• Knowledge and experience in developing, validating, and transferring methods for biologics, including cell-based assays and other functional other bioassays.
• Understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment.
• General understanding in CMC development strategy of biologics drugs.
• Strong communication skills (with both scientific and non-scientific audiences).

• Experience in the development of analytical assays for cell-based products including HSPCs and Tcells.
• Previous exposure to late-stage process development and CMC.
• Experience working in an environment focused on compliance and regulatory approval.

The anticipated annual salary range for this U.S. based job is $100,000– $175,000. 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.