Senior Research Associate, Drug Product Development

The Senior Research Associate will report to the Associate Director, Drug Product Development. The position will focus mainly on internal development and support external activities for performing sterile injectable drug product development activities for Sarepta’s Gene Therapy, PMO, and PPMO programs.

This position will work closely with Drug Product Operations, QA / QC, and Process Development teams to support ongoing and new programs within the Sarepta pipeline.

Primary Responsibilities Include :

• Designs and performs product characterization and formulation development experiments internally and supports activities at external contract testing laboratories throughout the drug product development process
• Experience with AAV gene therapy products, sterile injectables, and particle characterization is preferred
• Works closely with QC and Analytical Development to develop appropriate, well-characterized formulations, identify impurities, perform method development, and establish specifications
• Works across the organization to support internal drug product development laboratory capabilities at Sarepta’s Burlington and Andover, MA sites
• Facilitates drug product development activities including formulation development, characterization, filtration, container closure qualification, and extractable and leachable testing
• Participates in Tech Transfer of new processes to CMOs including change controls, manufacturing batch record development, troubleshooting, and process validation
• Performs feasibility assessments of new laboratory techniques and technology concepts
• Documents all experiments in lab notebooks and reports

Desired Education and Skills :

This role requires expertise in biophysical characterization and analytical tools for small molecules and biologics, understanding of sterile drug product development, as well as experience working with external contract development organizations.

Experience working with and characterizing gene therapies is a plus

• Ability and willingness to work in a laboratory setting are a must
• BS degree in Chemistry, Chemical Engineering, Biochemical / Biomedical Engineering or related science field. MA / MS degree preferred.

5+ years of related experience

• Understanding of formulation approaches to stabilizing against degradation in liquid or lyophilized dosage forms
• Experience developing and utilizing analytical methods for drug product characterization
• Knowledge and experience using biochemical or biophysical methods to characterize AAV-based viral vectors is desired but not required
• Ability to work cross-functionally and communicate effectively across CMC functional areas
• Experience with regulations and requirements such as cGMP, ICH, USP
• Strong written and oral communication skills are required
• Willingness to learn new techniques and strategies to support drug product development capabilities
• Position may require some travel (expected to be minimal)

LI-Onsite

This position requires work on site at one of Sarepta’s facilities in the United States.

The targeted salary range for this position is $80,000 - $100,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges.

The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity / Affirmative Action employer and participates in e-Verify.