What are the responsibilities and job description for the Senior Scientist, Analytical Development position at 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 a Senior Scientist to drive the development of analytical assays and internal teams to support CDMO partners for the GMP production of lentiviral vectors and CAR/TCR drug products. The Senior Scientist will report into Outpace Technical Operations and will be responsible for managing analytical projects within CMC timelines, authoring analytical development reports, overseeing early phase analytical method and technology transfer from the Outpace R&D team, and conducting hands-on, technical laboratory work. This position will report to the Senior Director of Technical Operations 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 will include developing internal processes and assays for tech transfer to CDMOs and CROs, communicating to internal and external stakeholders, and providing necessary technical support for regulatory submissions.
Responsibilities (Position responsibilities may include, but are not limited to):
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.
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 a Senior Scientist to drive the development of analytical assays and internal teams to support CDMO partners for the GMP production of lentiviral vectors and CAR/TCR drug products. The Senior Scientist will report into Outpace Technical Operations and will be responsible for managing analytical projects within CMC timelines, authoring analytical development reports, overseeing early phase analytical method and technology transfer from the Outpace R&D team, and conducting hands-on, technical laboratory work. This position will report to the Senior Director of Technical Operations 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 will include developing internal processes and assays for tech transfer to CDMOs and CROs, communicating 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 and Validation:
- Design, develop, and validate robust analytical methods for characterizing CAR/TCR-T cell therapies and lentiviral vectors
- Develop assays to evaluate product identity, purity, potency, safety, and stability
- Implement and optimize innovative techniques such as 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:
- Author and review regulatory filings, technical reports, and standard operating procedures for compliance with FDA, EMA, and other regulatory agencies
- Ensure adherence to cGMP and ICH guidelines in all analytical activities
- Technology Evaluation:
- Stay current on emerging analytical technologies and apply innovative approaches to enhance method capabilities
- Evaluate and implement new tools and platforms for CAR/TCR-T and lentiviral vector product characterization
- Data Analysis and Interpretation:
- Analyze complex datasets and present findings to internal stakeholders
- Contribute to troubleshooting and problem-solving activities for analytical methods and product quality issues
- Mentorship and Leadership:
- Mentor and guide junior scientists, fostering a culture of scientific excellence and continuous improvement
- Lead or contribute to project teams, ensuring timely delivery of analytical deliverables
- Coordinate with process development, manufacturing, quality assurance, and regulatory teams to align analytical strategies with overall project goals
- Education:
- Ph.D. in Analytical Chemistry, Biochemistry, Cell Biology, or a related field with 3 years of relevant experience, or
- M.S. with 6 years of experience, or
- B.S. with 8 years of experience in analytical development within the biotechnology or biopharmaceutical industry
- Technical Expertise:
- Strong background in analytical techniques used for cell and gene therapy, including flow cytometry, qPCR/ddPCR, ELISA, and cell-based assays
- Experience with method development, qualification, and validation per regulatory standards
- Familiarity with bioassay design and characterization for potency and functional evaluation of CAR/TCR-T and lentiviral vector products
- Strong understanding of cell therapy manufacturing processes and quality control, including experience interacting with CDMOs and other GMP-compliant facilities
- Regulatory Knowledge:
- Knowledge of cGMP, ICH guidelines, and regulatory requirements for cell and gene therapy products
- Experience authoring regulatory submissions such as INDs, BLAs, or equivalent
- Soft Skills:
- 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
- Prior experience in development of CAR-T or TCR-T cell therapies
- Knowledge of statistical analysis and software tools such as JMP, Prism, or equivalent
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.
Salary : $144,000 - $160,000
