--- title: 'Senior / Principal Scientist, CMC Analytical Development at Orca Bio' canonical: 'https://feeny.ai/job/senior-principal-scientist-cmc-analytical-development-orca-bio-sacramento-11apfdw6byw1' type: 'job' last_seen: '2026-10-16' --- # Senior / Principal Scientist, CMC Analytical Development at Orca Bio - **Company:** Orca Bio - **Location:** Sacramento, CA - **Compensation:** $120k–$170k - **Employment:** full-time - **Work type:** onsite - **Posted:** 2026-10-13 - **Last confirmed live:** 2026-10-16 - **Apply:** https://jobs.lever.co/orcabiosystems/e130af89-b0fa-460d-b525-dcec3adc8df7 ## Job description 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. ## 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. ## About Orca Bio ## Company Overview - **One-liner**: Orca Bio is a clinical-stage biotechnology company developing high-precision cell therapies to cure blood cancer, genetic blood disorders, and autoimmune diseases without the severe side effects of traditional transplants. - **Entity Type**: Private (Late-Stage Biotech) - **Headquarters**: Menlo Park, California, USA - **Founded**: 2016 - **Founders**: Not publicly available (leadership team has delivered on mission since founding) ## Core Business - **Primary Industry**: Biotechnology / Cell Therapy / Pharmaceutical Manufacturing - **Target Customers**: B2B — healthcare providers, transplant centers, and oncology clinics; ultimately serving patients with hematologic malignancies, genetic blood disorders, and autoimmune diseases - **Mission Statement**: "To deliver a cure without compromise for patients through high precision cell therapies" [orcabio.com](https://orcabio.com/join-our-team/) ## Products & Services - **Orca-T (Lead Therapy)**: Allogeneic T-cell immunotherapy designed to treat hematologic malignancies (AML, ALL, MDS, MPAL). It is a high-precision cell therapy that isolates the less than 1% of cells that provide therapeutic benefit from a standard transplant, aiming to improve survival rates while reducing risks of chronic GvHD. Received **Regenerative Medicine Advanced Therapy (RMAT)** designation and **Orphan Drug Designation** from the FDA. BLA accepted under **Priority Review** in October 2025, with a PDUFA target action date of **April 6, 2026** [siliconvalleyinvestclub.com](https://siliconvalleyinvestclub.com/companies/orca-bio/). - **Orca-Q**: Designed to treat acute leukemias for patients without a fully matched donor. - **OrcaSort Platform (Enabling Technology)**: Proprietary single-cell sorting and purification technology that isolates specific immune and stem cell populations at high precision and scale — the foundation enabling all Orca Bio’s therapies. - **Other Pipeline Therapies**: Intended to treat a broad array of non-malignant blood and immune system disorders. ## Market Standing - **Valuation**: Not publicly disclosed (privately held) - **Total Funding**: **$542M** across 7 rounds (Seed, Series D, Series F, and others) [search results] - **Key Funding Events**: - **Series F (Jan 2026)**: **$250M** led by **Lightspeed Venture Partners** [siliconvalleyinvestclub.com](https://siliconvalleyinvestclub.com/companies/orca-bio/) - **Series D (Jun 2020)**: **$192M** led by **Lightspeed Venture Partners** (11 investors total) - **Annual Revenue**: **$13.5M** (estimated) - **Notable Investors/Partners**: Lightspeed Venture Partners; clinical trial partners include City of Hope, Stanford Health Care, UC Davis, Oregon Health & Sciences University, University of Texas MD Anderson Cancer Center, Sarah Cannon Research Institute [orcabio.com](https://orcabio.com/wp-content/uploads/2022/03/orcabio-corporate-factsheet.pdf) - **Growth Signals**: - Headcount grew **72.3% YoY** to **283 employees** [search results] - Phase 3 primary endpoint met (Feb 2025) - BLA under FDA Priority Review with PDUFA date April 6, 2026 — potential FDA approval and commercial launch imminent - 200+ patients treated in clinical trials to date - Ramping up manufacturing operations with multiple new hires across manufacturing, quality, and operations ## Competitive Advantages - **Precision Cell Sorting Platform**: Orca Bio’s proprietary technology sorts the more than 100 billion cells in a standard allogeneic transplant down to the less than 1% that actually provide therapeutic benefits, creating a high-precision proprietary mixture of immune and stem cells to build a designer immune system for patients. - **Reduced Side Effects**: Designed to control serious complications like chronic GvHD while enabling a potent anti-cancer effect — a significant improvement over traditional transplants. - **Manufacturing Speed**: Consistently achieved donor-to-patient vein-to-vein turnaround times of less than 72 hours across ongoing clinical trials. - **Regulatory Momentum**: RMAT designation and FDA Priority Review for lead therapy Orca-T signal strong regulatory alignment and potential for accelerated path to market. ## Strategic Focus - **Commercialization Readiness**: With a $250M Series F raised in Dec 2025/Jan 2026 and a PDUFA date in April 2026, the company is aggressively scaling manufacturing, quality, and commercial operations to prepare for a potential product launch. - **Manufacturing Scale-Up**: Significant hiring across manufacturing, MSAT, packaging, and cold chain handling roles in Sacramento and Menlo Park. - **Pipeline Expansion**: Advancing Orca-Q for patients without fully matched donors and expanding into broader non-malignant blood and immune system disorders. - **Building the Commercial Organization**: Recent hires include a Chief Commercial Officer (Mike Hirschmann) and Associate Director of Market Development (Mid-West), signaling preparation for a U.S. commercial launch. ## Why Work Here - **Mission-Driven Impact**: "Deliver the promise of a cure, without compromise" — employees work directly on therapies that could transform the lives of patients with blood cancer and serious immune disorders [orcabio.com](https://orcabio.com/join-our-team/) - **Start-Up Culture with Late-Stage Resources**: Described as maintaining a "start-up culture of camaraderie" while being well-funded ($542M total) and approaching a major regulatory milestone [orcabio.com](https://orcabio.com/join-our-team/) - **Rapid Growth & Career Opportunity**: Headcount grew 72% YoY; 36 active job postings at time of research across manufacturing, quality, analytical development, and commercial roles - **Work Environment**: On-site roles in Menlo Park, CA (HQ) and Sacramento, CA (manufacturing facility). Roles span day, night, and 2nd/3rd shifts for manufacturing positions. - **Culture Ratings**: 3.7/5.0 overall on employer review sites (Culture: 3.9, Career: 3.7, Compensation: 3.4, Work-Life: 3.1) - **Top Talent Sources**: Employees come from Genentech, UC Davis, Stanford, BioMarin, Cepheid, Omeros — strong biotech pedigree - **Notable Perks**: Opportunity to work at the cutting edge of cell therapy with a platform that has real potential to change standard of care in transplant medicine ## Sources 1. [orcabio.com - Official Website](https://orcabio.com/join-our-team/) 2. [orcabio.com - Corporate Factsheet](https://orcabio.com/wp-content/uploads/2022/03/orcabio-corporate-factsheet.pdf) 3. [jobs.lever.co/orcabiosystems - Careers Page](https://jobs.lever.co/orcabiosystems) 4. [siliconvalleyinvestclub.com - Orca Bio Profile](https://siliconvalleyinvestclub.com/companies/orca-bio/) 5. [linkedin.com/company/orcabio - LinkedIn](https://linkedin.com/company/orcabio) ## Other roles at Orca Bio - [Associate Director, Orca Account Management - Midwest (IA, IL, IN)](https://feeny.ai/job/associate-director-orca-account-management-midwest-ia-il-in-orca-bio-illinois-hw4tnvwb2brt) — Illinois - [Material Planner](https://feeny.ai/job/material-planner-orca-bio-sacramento-tmfkt0ga77ne) — Sacramento, CA - [Manager, Warehouse](https://feeny.ai/job/manager-warehouse-orca-bio-sacramento-awqj1stjk08h) — Sacramento, CA - [Manager / Senior Manager, Business Systems](https://feeny.ai/job/manager-senior-manager-business-systems-orca-bio-sacramento-9kkyjptn9asw) — Sacramento, CA - [Medical Director / Senior Medical Director, Clinical Development](https://feeny.ai/job/medical-director-senior-medical-director-clinical-development-orca-bio-menlo-whhrnkz37zh5) — Menlo Park, CA - [Manager, Quality – Commercial Site Onboarding (East Coast)](https://feeny.ai/job/manager-quality-commercial-site-onboarding-east-coast-orca-bio-remote-1a3rz045kad9) - [Director, Medical Information](https://feeny.ai/job/director-medical-information-orca-bio-menlo-park-yen9at2h6zrd) — Menlo Park, CA - [National Senior Director, Field Medical Affairs](https://feeny.ai/job/national-senior-director-field-medical-affairs-orca-bio-menlo-park-gqqfr6jj7egy) — Menlo Park, CA - [Coordinator, Commercial Marketing and MLR](https://feeny.ai/job/coordinator-commercial-marketing-and-mlr-orca-bio-remote-jec414fh179h) - [Medical Science Liaison - Great Lakes (IL, MI, MN, WI, IN, IA, ND, SD)](https://feeny.ai/job/medical-science-liaison-great-lakes-il-mi-mn-wi-in-ia-nd-sd-orca-bio-remote-zc16fwhh5w50)