Associate Director, Analytical Development - AAV

Location
Bedford, Massachusetts (US)
Posted
Sep 03, 2019
Required Education
Doctorate/PHD/MD
Position Type
Full time

Associate Director, Analytical Development - AAV

Location: Bedford, MA

Job Summary

The role of Analytical Development Associate Director is to lead the development and implementation of analytical methods to characterize HMI’s proprietary adeno-associated viral (AAV) vector products. This individual will be a motivational and highly-skilled researcher who will lead a team in the analysis of research and development-grade vector samples using innovative analytical methods to aid in defining the physicochemical characteristics of our novel AAV products. The successful candidate will coordinate the comparison of AAV vector products produced internally with those produced externally through the development, optimization, qualification and transfer of analytical assays using chromatographic, spectroscopic and electrophoretic methods. We seek candidates with a demonstrated ability to successfully lead a team of analysts and to work cross-functionally, with the ultimate goal of delivering products that transform the lives of patients.

 

Essential Functions and Duties

 

  • Lead efforts to design and implement methods for the physicochemical characterization of AAV gene therapy/gene editing products.
  • Lead and support tech transfer of analytical methods to internal and external quality, development and manufacturing organizations.
  • Serve as a subject matter expert for Analytical Development on CMC teams.
  • Plan and direct the development of novel analytical studies and strategies for characterization of AAV gene therapy/gene editing products.
  • Present development study results and project updates.
  • Lead the authoring of technical reports and CMC sections for regulatory filings.
  • Manage a group of talented scientists, with a strong focus on personal career development and maintaining/nurturing HMI’s unique “no drama” corporate culture.

 

Skills and Experience:

 

  • BA/BS in Biological Sciences with 12+ years, MS with 10+ years or PhD with 6+ years of relevant industrial experience. Experience in analytical method development required.
  • A strong background in analytical characterization for biologics, including, but not limited to, chromatography, electrophoretic and spectroscopic characterization methods.
  • Experience with analytical method development for AAV and/or other viral vectors or vaccines is highly preferred.
  • Experience working on CMC teams is required.
  • Direct management experience of research or development teams is required.
  • Able to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
  • Experience working under GLP and GMP practices is strongly preferred.
  • Experience with method transfer to internal and external testing organizations to support characterization and release of clinical stage products is required.
  • Independently motivated, detail oriented and good problem-solving ability.

 

Homology Medicines, Inc. (HMI) has built foundational intellectual property on gene editing and gene therapy vectors derived from naturally occurring human adeno-associated viruses (AAVs). The Company's technology is precise, on-target and highly efficient for in vivo editing of genetic mutations. This transformative platform technology, combined with an elite leadership team of biopharmaceutical industry veterans, create a significant opportunity for HMI to rapidly advance a diverse pipeline of new medicines that address and potentially cure the underlying cause of genetic diseases.