The Role
Contract Research Associate supporting Analytical Development to develop, optimize, qualify, and validate analytical methods for cell therapy products; perform hands-on laboratory studies, generate and document data, author SOPs/protocols, collaborate cross-functionally, and maintain equipment and compliance.
Summary Generated by Built In
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 investigational 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.
Physical Demands
- Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
- Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
Work Conditions
- Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.
Position Summary
- Participate in a team focused on the characterization, qualification, and validation of analytical methods for cell therapy products.
- Execute laboratory-based studies to develop, optimize, qualify, and validate analytical methods for the analysis of cell therapy products.
- Generate, analyze, and accurately document experimental data in accordance with established procedures and quality standards.
- Author and review laboratory documentation, including standard operating procedures (SOPs), analytical methods, qualification and validation protocols, technical reports, and other laboratory processes.
- Collaborate with cross-functional teams to support analytical development activities and project timelines.
- Maintain laboratory equipment, reagents, and workspaces while adhering to laboratory safety and compliance requirements.
Orca Bio is seeking a Contract Research Associate to support the Analytical Development team. This lab-based role will contribute to the characterization, qualification, and validation of analytical methods used to support the development of cell therapy products. The successful candidate will perform hands-on laboratory studies, maintain accurate documentation, and collaborate with a multidisciplinary team to advance analytical method development and validation.
Key Responsibilities
Qualifications
- Hands-on experience with analytical techniques such as:
- Flow cytometry
- Mammalian cell culture and aseptic technique
- ELISA and other immunoassays
- qPCR/PCR
- Cell viability and cell counting assays
- Cell-based functional assays (e.g., proliferation, activation, cytotoxicity)
- Fluorescence or brightfield microscopy
- Experience with data analysis software such as FlowJo, GraphPad Prism, and Microsoft Excel.
- Familiarity with analytical method qualification and validation.
- Experience working in a regulated laboratory environment (GLP, GMP, or similar) is a plus.
Preferred Qualifications, but do not have to have all of them:
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.
Skills Required
- Perform hands-on laboratory studies to develop, optimize, qualify, and validate analytical methods
- Generate, analyze, and accurately document experimental data in accordance with procedures and quality standards
- Author and review laboratory documentation including SOPs, protocols, and technical reports
- Collaborate with cross-functional teams to support analytical development activities and timelines
- Maintain laboratory equipment, reagents, workspaces and adhere to laboratory safety and compliance requirements
- Hands-on experience with flow cytometry
- Mammalian cell culture and aseptic technique
- ELISA and other immunoassays
- qPCR / PCR experience
- Cell viability and cell counting assays
- Cell-based functional assays (proliferation, activation, cytotoxicity)
- Fluorescence or brightfield microscopy
- Experience with FlowJo, GraphPad Prism, and Microsoft Excel
- Familiarity with analytical method qualification and validation
- Experience working in a regulated laboratory environment (GLP, GMP, or similar)
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The Company
What We Do
Orca Bio is a clinical-stage biotechnology company developing a pipeline of high precision allogeneic cell therapy products that are designed to safely replace patients’ diseased blood and immune system with a healthy one. Our manufacturing platform sorts donor blood with single-cell precision and a high level of purity and speed, enabling us to create proprietary, optimal therapeutic mixtures of immune and stem cells that have the potential to transform allogeneic cell therapy. Our talented team is driven by a passion for science and compassion for patients.
