Research Associate II/Senior Research Associate, Analytical Development - Outpace Bio

About Outpace Bio

Outpace Bio is pioneering the future of cell therapy for solid tumors by harnessing unrivaled AI-powered protein design. Our mission is to program immune cells for enhanced function inside patients, overcoming key barriers such as poor tumor access, weak survival, antigen escape, and dose-related toxicity. By creating and integrating modular, plug-and-play technology assets, we are developing cell therapies with unprecedented efficacy, transforming how engineered T cells interact with cancer and the immune system to deliver life-changing outcomes. Our multidisciplinary team of scientists, engineers, coders, and cell therapy developers works at the cutting edge of computational protein design, synthetic biology, and immunology. Together, we are reimagining how cells function to unlock novel therapeutic possibilities. Located in Seattle’s vibrant biotech hub overlooking scenic South Lake Union, Outpace Bio is led by pioneers in computational protein design and engineered cell therapies. Our culture is built on a foundation of respect and inclusion, which are fundamental to how we collaborate to revolutionize cell therapy through groundbreaking innovation rooted in rigorous science.

Our Commitment to Diversity

At Outpace Bio, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences. We are committed to cultivating an open, diverse, and inclusive culture for all employees. Recognizing that the best candidates do not always match all criteria of the job description, we encourage you to apply if you think you would be a good fit for the role and are inspired by our mission to cure disease by pushing the boundaries of biology.

Our Momentum

In August 2024, Outpace Bio secured an oversubscribed $144 million Series B financing, led by RA Capital Management and supported by a premier syndicate of life science investors. This funding accelerates our pipeline of programmed T cell therapies, including our lead candidate OPB-101, a mesothelin-specific chimeric antigen receptor (CAR) T cell enhanced by Outpace’s proprietary OUTSMART, OUTLAST, OUTSPACER, and OUTSAFE technologies. OPB-101 is advancing toward IND clearance and first dosing in 2025 for patients with advanced platinum-resistant ovarian cancers. The Series B investment also supports the expansion of our pipeline, enabling us to develop additional transformative therapies leveraging our innovative plug-and-play technology platform.

Outpace Bio is seeking an Research Associate II/Senior Research Associate to support development of analytical assays and technology transfer to CDMO partners for the GMP production of lentiviral vectors and CAR/TCR drug products. As a member of the Technical Operations team, the Research Associate II/Senior Research Associate will contribute to analytical development projects supporting CMC activities, authoring analytical development reports, advancing early phase analytical method transfer from the Outpace R&D team, and conducting hands-on, technical laboratory work. This position will report to the Senior Scientist, Analytical Development and will work closely with R&D functional groups (Platform, Immunology, CAR T development) as an integral part of project teams. Key contributions expected from this role include novel assay development, support for internal process and assay technology transfer to CDMOs and CROs, communications to internal and external stakeholders, and providing necessary technical support for regulatory submissions.

Responsibilities (Position responsibilities may include, but are not limited to):

• Method Development:
  • Support design and development of robust analytical methods for characterizing CAR/TCR-T cell therapies and lentiviral vectors
  • Establish assays to evaluate product identity, purity, potency, safety, and stability
  • Implement novel methods including flow cytometry, qPCR/ddPCR, ELISA, cell-based assays, and chromatography to support comprehensive product characterization
• Analytical Support:
  • Support process development, product characterization, and comparability studies for CAR/TCR-T and lentiviral vector manufacturing
  • Collaborate with cross-functional teams in Process Development, Quality, Regulatory, Immunology, and Pipeline to generate high-quality data for decision-making and regulatory submissions
• Regulatory and Compliance:
  • Review regulatory filings, technical reports, and standard operating procedures for compliance with FDA, EMA, and other regulatory agencies
• Data Analysis and Interpretation:
  • Contribute to analysis of complex datasets and present findings to internal stakeholders
  • Contribute to troubleshooting and problem-solving activities for analytical methods and product quality issues
• Leadership:
  • Foster a culture of scientific excellence and continuous improvement
  • Contribute to project teams objectives, ensuring timely delivery of analytical deliverables
  • Coordinate with process development, manufacturing, quality assurance, and regulatory teams to align analytical strategies with overall project goals

Qualifications (Required):

• B.S. or M.S. in Biology, Biochemistry, Immunology, Molecular Biology, Analytical Chemistry, Biotechnology, or related disciplines
• M.S with 0-2+ years or B.S. with 2-4+ years of experience in analytical development in the cell and gene therapy industry
• Strong background in standard analytical techniques used for cell and gene therapy, including flow cytometry, qPCR/ddPCR, ELISA, and cell-based assays
• Experience with method development and qualification
• Familiarity with bioassay design and characterization for potency and functional evaluation of CAR/TCR-T and lentiviral vector products
• Strong problem-solving skills and the ability to work in a fast-paced, collaborative environment
• Excellent communication skills, both written and oral, with the ability to present complex data clearly
• Periodic domestic travel to CDMOs

Qualifications (Preferred):

• Understanding of cell therapy manufacturing processes and quality control, including experience interacting with CDMOs, preferred
• Knowledge of statistical analysis and software tools such as JMP, Prism, or equivalent, preferred
• Knowledge of cGMP, ICH guidelines, and regulatory requirements for cell and gene therapy products, preferred
• Experience authoring regulatory submissions such as INDs, BLAs, or equivalent, preferred

$73,000 - $105,000 a year

This position is a Research Associate II/Senior Research Associate level position, with a compensation range of $73,000-$85,000 for a Research Associate II position and $90,000-$105,000 for a Senior Research Associate position. Actual compensation is dependent upon current market data, experience, and pay parity at Outpace.

The salary range is based on Outpace Bio's reasonable estimate of base salary for this role at the time of posting. Actual base salary will be based on a variety of factors including skills, experience, and other related factors permitted by law.

Working at Outpace offers an exciting opportunity to contribute to groundbreaking research that has the potential to transform the lives of people around the world.

Outpace Bio Total Rewards

Full time employees and their eligible dependents may enroll in Outpace's medical, dental, vision, life insurance, disability, flexible spending account, and 401k plan. In addition, employees may receive stock option grants to be outlined in their offer of employment and a performance bonus. Outpace employees enjoy flexible PTO, paid sick leave which complies with local requirements, and fifteen paid holidays plus a winter shutdown. Outpace also offers a generous paid parental leave policy to all regular full-time employees.

Outpace Bio is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply.