Principal Research Associate/Scientist, Analytical Development
Affinia Therapeutics is an innovative gene therapy company focused on broadening the reach of gene therapy. Our proprietary Affinia Rationally-designed Therapies (ART) platform is created to address key limitations of conventional gene therapies, by developing novel capsids, novel promoters, and novel manufacturing approaches to developing gene therapies for rare and prevalent devastating diseases. We are backed by a strong syndicate of life science investors and have ambitious plans to have a dramatic impact on the lives of patients around the world.
You will play a key role in shaping our culture and embodying our values of integrity, passion, and teamwork. You will be working alongside the founding management team who have a track record of success in the industry. The pace of work is dynamic, fast, and fun.
We are looking for a curious, passionate, and driven individual to work with our team at Affinia Tx. Team members work together to straddle the lines between research, development, and business operations. This is an excellent opportunity to lead and grow in a dynamic, next-generation gene therapy environment.
Affinia Tx is seeking an experienced, enthusiastic and dedicated scientist to join our Analytical Development laboratory team. You will be part of a group dedicated to the advancement of therapeutic products based on vectors derived from our unique AAV therapeutic platform.
As a member of the Analytical Development laboratory team, you will contribute to the development of fit-for-purpose bioassays to support our process development and manufacturing activities. In addition, you will analyze samples and work cross-functionally with other laboratory teams to generate data and transfer methods. You will contribute to the evaluation of new analytical technologies and the development of more efficient laboratory workflows to maintain our culture of quality and excellence.
This position reports to the Associate Director of Analytical Science and is located at our site in Waltham, MA.
- Lead efforts to develop fit-for purpose molecular and cellular bioassays to support non-GMP characterization of research and process development material
- Perform analysis of in process and drug substance samples using qualified analytical methods
- Contribute as an analytical subject matter expert to support analytical development activities at external CRO and CDMO laboratories
- Collaborate with the Computational Biology and Process Science/Vector Core teams to build up a system for sample and testing result management
- Execute assay qualification or validation activities for selected analytical methods according to appropriate guidelines (GMP, ICH)
- Assist with the transfer of qualified assay methods to cross-functional teams and CDMO/CRO partners
- Author and review SOPs, test methods and other controlled documents in the validated QMS document management system
- Implement and document new laboratory workflows and continuous improvement efforts
- Supervise and/or mentor junior team members assisting with the above activities.
- Ph.D. degree in a relevant scientific field with 0-2 years of industry experience, or M.S. degree in a relevant scientific field with 4+ years of industry experience, or Bachelor degree in a relevant scientific field with 6+ years of industry experience
- Experience in analytical methods associated with gene therapy drug product characterization (titer, purity, contaminants, potency)
- Hands-on experience in the development and qualification of ddPCR/qPCR-, ELISA-, and cell-based bioassays
- A strong record of demonstrating analytical reasoning and creative problem-solving skills in a laboratory environment, including common statistical analysis methods and software related to method development and validation
- A strong record of organizational and multitasking skills in an analytical laboratory setting
- Good written and oral communications skills, including experience writing laboratory SOPs, protocols and reports
- Experience in cell-based assays such as TCID50, in vitro potency and neutralizing antibody assays is particularly desirable
- Experience in working in a small startup and fast-paced environment
- Previous experience working in a BSL-2 laboratory
- Previous experience working in a quality-regulated laboratory environment
EEO Statement: Affinia Therapeutics is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.