Posted in Other 12 days ago.
Type: Full Time
The Sr. Associate reports to the Director of Formulation Development, Drug Product Development & Manufacturing. The position will focus mainly on internal development and support external activities for performing sterile injectable drug product development activities for Sarepta s PMO, PPMO and Gene Therapy programs. This position will work closely with Drug Product Operations, QA/QC, and process development teams to support ongoing and new programs.
PRIMARY RESPONSIBILITIES INCLUDE:
* Performs product characterization and formulation development experiments internally and support external contract testing laboratories for development and scale down activities throughout the drug product development process
* Experience with sterile injectables and particle characterization is preferred
* Works closely with QC and Analytical Development to develop appropriate, well-characterized formulations, identify impurities, method development, and specifications
* Works across the organization to support internal drug product development laboratory capabilities at Sarepta s Andover and Burlington, MA sites
* Facilitate drug product development activities including formulation development, filtration, container closure qualification, and extractable and leachable testing
* Participate Tech Transfer of new processes to CMOs and participating in change controls, manufacturing batch record development, troubleshooting, and process validation
* Feasibility assessments of new laboratory techniques and technology concepts
EDUCATION AND SKILLS REQUIREMENTS:
* MS with 2+ years or BS with 5+ years experience in Chemistry, Chemical Engineering, Biochemical Engineering or related science field
* 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
* Ability and willing to work in a laboratory setting are must
* 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
* Ability to work in a laboratory setting
* Position may require some travel and the ability to be flexible across Sarepta sites
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.