More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
Summary:
In this role, you will own analytical development for potency, mechanism of action, product characterization, and release testing methods supporting early- and late-stage cell therapy programs. You will also author CMC analytical content for BLA submissions and help prepare our programs for commercialization. The ideal candidate is a hands-on, seasoned scientist with strong flow cytometry and cell-based assay expertise, experience taking methods through validation and transfer, and a track record of working closely with Process Development, Manufacturing, QC, and Quality.
Key Responsibilities
Method Development, Validation & Transfer
Develop and optimize multiparametric flow cytometry and cell-based functional assays for cell therapy products.
Lead validation of analytical methods for release and stability testing, including writing and reviewing protocols and reports.
Drive method transfers between sending and receiving labs, including the overall transfer plan, protocols, execution of transfer testing, and reports.
Characterization, Potency & Mechanism of Action
Perform extended characterization of product, including biological activity, potency, and mechanism of action studies.
Support analytical comparability and product stability studies.
Interpret experimental results and perform data analysis using appropriate software.
Serve as subject matter expert for one or more analytical technologies such as flow cytometry, bioassays, cell counting, particle testing, or potency methods.
Regulatory & Commercialization
Author CMC analytical content for BLA submissions and commercial launch preparation, including specifications, method development and validation, potency and mechanism of action studies, comparability, and stability.
Author and review protocols, technical reports, method SOPs, and regulatory submission sections.
Collaboration & Communication
Partner with Process Development, Manufacturing, QC, QA and other teams.
Prepare and present data summaries and project updates to stakeholders and at cross-functional team meetings.
Required Qualifications
Education & Experience
PhD in Pharmaceutical Sciences, Biology, Immunology, Cell Biology, or a related field with 5-8+ years of relevant industry experience.
M.S. candidates may be considered with an outstanding track record in analytical development and the drug product process development.
Technical Expertise and Core Skills
Substantial expertise in flow cytometry and cell-based assay technologies.
Experience with immune functional assays in cell therapy and/or biologics analytical development or quality control laboratories.
Working knowledge of QC and cGMP requirements for the biopharmaceutical industry, including relevant USP methodologies and ICH guidelines.
Experience working with and leading cross-functional teams, such as CMC and clinical development teams.
Strong written and verbal communication skills.
Self-starter with strong interpersonal, planning, and tracking skills.
Ability to manage multiple competing priorities in a fast-paced, changing environment.
Preferred Qualifications:
History with commercialization projects and a successful track record of BLA or IND authorship.
Experience in cGMP cell therapy and/or biological product manufacturing, particularly with immunological systems, cell therapy, gene therapy, or individualized patient therapies.
Expertise in flow cytometry assay development and validation
