Research Associate II/Senior Research Associate, Analytical Development

Outpace Bio; Seattle (WA); On-site; USD 73,000 - 105,000; Full time

Job summary

An innovative firm at the forefront of cell therapy is seeking a Research Associate to join their dynamic team in Seattle. This role offers the opportunity to engage in cutting-edge analytical development for CAR/TCR therapies and lentiviral vectors. Collaborating with a multidisciplinary team, you will design and implement analytical methods, support regulatory compliance, and contribute to groundbreaking research that pushes the boundaries of science. If you are passionate about making a difference in the biotech industry and thrive in a collaborative environment, this position is perfect for you.

Benefits

Health Insurance

Stock Options

Flexible PTO

Paid Parental Leave

Qualifications

• B.S. or M.S. in a relevant field with 0-4+ years of experience in analytical development.
• Strong background in analytical methods and problem-solving skills.

Responsibilities

• Develop and implement analytical methods for CAR/TCR-T therapies.
• Support regulatory submissions and compliance with FDA and EMA.

Skills

Flow Cytometry

qPCR/ddPCR

ELISA

Cell-based Assays

Problem-solving

Communication Skills

Education

B.S. in Biology

M.S. in Biochemistry

M.S. in Immunology

M.S. in Analytical Chemistry

M.S. in Biotechnology

Tools

Statistical Analysis Software (JMP, Prism)

Job description

Research Associate II/Senior Research Associate, Analytical Development

Join to apply for the Research Associate II/Senior Research Associate, Analytical Development role at Outpace Bio

About Outpace Bio

Outpace Bio is pioneering the future of cell therapy for solid tumors by harnessing AI-powered protein design. Our mission is to program immune cells for enhanced function inside patients, overcoming barriers such as poor tumor access, weak survival, antigen escape, and dose-related toxicity. We develop cell therapies with unprecedented efficacy by creating modular, plug-and-play technology assets, transforming how engineered T cells interact with cancer and the immune system. Our multidisciplinary team works at the forefront of computational protein design, synthetic biology, and immunology, reimagining cell functions to unlock new therapeutic possibilities.

Located in Seattle’s biotech hub overlooking 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 our collaboration and innovation.

Our Commitment to Diversity

We believe that high-performing teams include diverse backgrounds and experiences. We are committed to cultivating an open, inclusive culture for all employees. We encourage applications from candidates who believe they are a good fit and are inspired by our mission to cure disease by pushing biological boundaries.

Position Overview

Outpace Bio seeks a Research Associate II/Senior Research Associate to support analytical assay development and technology transfer for GMP production of lentiviral vectors and CAR/TCR drug products. Reporting to the Senior Scientist, Analytical Development, the role involves analytical development projects, authoring reports, and hands-on laboratory work. Key responsibilities include assay development, process and assay transfer support, stakeholder communication, and regulatory support.

Responsibilities

1. Method Development: Design and develop analytical methods for characterizing CAR/TCR-T therapies and lentiviral vectors; establish assays for product identity, purity, potency, safety, and stability; implement techniques like flow cytometry, qPCR/ddPCR, ELISA, and chromatography.
2. Analytical Support: Support process development, product characterization, and comparability studies; collaborate with cross-functional teams to generate data for decision-making and regulatory submissions.
3. Regulatory and Compliance: Review regulatory filings, reports, and SOPs for compliance with FDA, EMA, and other agencies.
4. Data Analysis and Interpretation: Analyze complex datasets, present findings, troubleshoot, and resolve analytical issues.
5. Leadership: Promote scientific excellence, contribute to project goals, and coordinate analytical strategies across teams.

Qualifications (Required)

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

Qualifications (Preferred)

• Understanding of cell therapy manufacturing and quality control, including CDMO interactions.
• Knowledge of statistical analysis software such as JMP, Prism, etc.
• Familiarity with cGMP, ICH guidelines, and regulatory requirements.
• Experience with regulatory submissions like INDs or BLAs.

Salary range: $73,000 - $105,000 annually, dependent on experience and role level. Outpace Bio offers comprehensive benefits, including health insurance, stock options, bonuses, flexible PTO, paid parental leave, and more.

Additional Information

This role is full-time, entry to senior level, based in Seattle, WA. We value diversity and encourage all qualified candidates to apply. Applicants must be authorized to work in the U.S. without sponsorship.