Senior / Principal Scientist, CMC Analytical Development

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

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.   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 who need them.   We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.   We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.   We maintain a start-up culture of camaraderie and leadership by example, regardless of title.   We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.   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 team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.