Sr. Scientist - Potency Assay Development

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).

Required Qualifications:

• 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).

Preferred Qualifications

• 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.