Associate Director/Director, 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 offer competitive salary and benefits with the ability to make a difference.
Position Summary
Affinia Therapeutics is seeking an experienced, innovative, passionate individual to serve in the role of Associate Director/Director, Analytical Development, within the Analytical Science team. As the head of Analytical Development, you will have the opportunity to build and lead a talented and high-performing team responsible for our inhouse analytical capabilities as well as taking a lead role in shaping Affinia’s end-to-end analytical control strategy and advancing the evolving field of AAV analytical testing and characterization. This is an exciting opportunity to make impactful contributions to the AAV gene therapy industry at multiple stages of product development, in capsid design and characterization, and cutting-edge manufacturing innovation.
This position is located at our state-of-the-art Affinia Therapeutics facility in Waltham, MA.
Primary Responsibilities
- Grow and lead a best-in-class Analytical Development team, including organizational design, hiring, performance management and employee development.
- Plan and execute the analytical testing responsibilities (e.g. Process Sciences support, testing and characterization of Research vector batches) with a consistently high level of timeliness and data quality.
- Continue to advance and improve Affinia’s in-house CMC analytical capabilities through new method development and establishment and leading the industry on improved and novel analytical techniques.
- Take a lead role in activities such as specification development, product characterization, reference standard creation and management, critical reagent creation and management, early phase product stability, analytical method validation and lifecycle management. Developing an end-to-end analytical control strategy that maximizes the benefit of analytical efforts and ensures success in product development.
- Develop and evolve processes and procedures to guide phase-appropriate analytical activities, govern laboratory activities, and ensure efficiency, effectivity, and quality in testing.
- Primarily responsible for the oversight of the Analytical Development’s laboratory space
- Represent Analytical Development on various project teams as well as cross-functional and governance structure meetings. As SME for Analytical Development, you will provide advice and guidance to the team members across the organization.
Qualifications
- Ph.D. in a relevant scientific field with 10+ years industry experience, or a M.S. with 12+ years industry experience.
- Experience in development and execution of analytical methods associated with gene therapy drug product characterization (titer, purity, contaminants, potency) , in particular prior proven success in AAV gene therapy analytical development and/or quality control is strongly desired.
- Strong knowledge in a variety of analytical method techniques, including cell-based assay, liquid chromatography, qPCR/dPCR, capillary electrophoresis, etc.
- A strong record of organizational skills, including systems implementation in an analytical laboratory setting preferably in an early stage start up environment.
- A strong record of demonstrating analytical reasoning and creative problem-solving skills.
- Excellent written and oral communications skills, including experience writing laboratory SOPs, protocols and reports
- Experience managing laboratory personnel
