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Sarepta Therapeutics
Andover, Massachusetts, United States
4 hours ago

Description

The Scientist I, Drug Product Development reports to the Director of Drug Product Development, Pharmaceutical Development and CMC. The position will focus mainly on establishing internal and external capabilities for performing sterile injectable drug product development activities for Sarepta’s PMO, PPMO and Gene Therapy programs. This position will work closely with Analytical Development, Global Supply Chain, QA/QC, Technical Development (MS&T), Regulatory Affairs, and CMC teams to implement new programs and manage changes.

Primary responsibilities include

  • Performs product characterization and formulation development experiments internally and externally, manages external contract testing laboratories for development and scale down activities throughout the drug product development process
  • Perform product and process characterization studies related to sterile injectables and particle characterization from early to late stage products
  • Facilitate drug product development activities including formulation development, filtration, container closure qualification, and extractable and leachable testing
  • Facilitate Tech Transfer of new processes to CMOs and participating in change controls, manufacturing batch record development, troubleshooting, and process validation
  • Feasibility assessments of new product and technology concepts
  • Author CMC regulatory submission documents and act as the CMC point of contact for early phase development as well as continuous development activities
  • Works closely with QC and Analytical Development to develop appropriate, well-characterized formulations, identify impurities, method development, and specifications
  • Works across the organization to develop new internal drug product development laboratory capabilities at Sarepta’s Andover and Burlington, MA sites

Desired Skills and Education: 

  • This role requires expertise in wide range of biophysical characterization tools for small molecules and biologics, understanding of sterile drug product development, as well as experience managing external contract development organizations. Experience in characterizing visible and sub-visible particles is a must.  
  • Ability and willing to work in a laboratory setting are must
  • Ph.D.  in pharmaceutical sciences, organic/physical/analytical chemistry, or chemical/biochemical engineering with 1-3+ yrs experience is required
  • Well-developed understanding of formulation approaches to stabilizing against degradation in liquid or lyophilized dosage forms
  • Experience creating and developing novel drug delivery solutions to difficult formulation challenges
  • 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
  • Strong leadership and interpersonal skills with the 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
  • Domestic and international travel required (less than 10%)

This position requires work on site at one of Sarepta’s facilities in the United States.  Candidates should be aware that Sarepta currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 in order to work on site. Newly hired employees must be vaccinated prior to their employment start date. Sarepta is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

Candidates must be authorized to work in the U.S. Sarepta offers a competitive compensation and benefit package Sarepta is an Equal Opportunity/Affirmative Action employer and participates in e-Verify



Job Information

  • Job ID: 60076462
  • Location:
    Andover, Massachusetts, United States
  • Position Title: Scientist I, Drug Product Development
  • Company Name For Job: Sarepta Therapeutics
  • Job Function: Drug Development,
    Scientist

Sarepta Therapeutics, headquartered in Cambridge, Massachusetts, is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates. For more information, please visit us at www.sarepta.com.

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