Associate Director, Upstream Process Development

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP)
  3. United States
Burlington, USA
Posting date: 01 Sep 2023

Proclinical is seeking an Associate Director, Upstream Process Development for a cutting-edge biopharmaceutical company located in Burlington, MA.

With input from senior leadership, this individual will be responsible for the new viral vector design and characterization for therapeutic use. Additionally, this role will be responsible for providing technical oversight to external activities and would support regulatory submissions and supporting the preparation of regulatory documentation.

Must be eligible to work in the US.

Job Responsibilities:

  • Lead a team of scientists to design, construct, produce and characterize viral vectors plasmids to enable efficacious AAV gene therapy
  • Develop novel next-generation sequencing methods to enable viral vector characterization as well as critical raw materials
  • Lead novel genetic engineering to improve upstream yield and quality in support of our gene therapy portfolio
  • Function as molecular biology SME, author and review relevant regulatory documents
  • Present and defend scientific findings and project progress in cross-functional project teams/initiatives. Write technical reports, protocols, and SOPs.
  • Provide training and guidance to team members on molecular biology techniques and relevant protocol/SOPs.
  • Stay abreast of relevant new technologies and published literature, including attending external technical forums and publish in first class journals
  • Demonstrate leadership and foster a team environment
  • Maintain good communications and collaboration with colleagues in other groups and departments
  • Contribute to equipment procurement and maintenance, laboratory set up and organization

Skills and Requirements:

  • Ph.D. degree in molecular biology, virology, genetics, biochemistry or a related discipline with a minimum 6 years of experience in gene therapy or related fields OR M.S. degree in related disciplines with a minimum 9 years of relevant experience OR B.S. degree in related field with a minimum 12 years of relevant experience
  • Strong expertise and hands-on experience in molecular biology and Next Generation Sequencing
  • Demonstrated excellence in AAV engineering and analytics and/or viral vector biology
  • Strong computational background with experience analyzing large data sets
  • Expertise in CRISPR/Cas9 or other genome editing approaches is preferred
  • Strong work ethic and demonstrated ability to manage a small team
  • Excellent time and project management skills, and ability to work on multiple projects simultaneously
  • Excellent organization, written and oral presentation skills

If you are having difficulty in applying or if you have any questions, please contact Jessika Rodriguez at +(1) 617-391-0929 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.