Associate II, Nucleoside Manufacturing

Company Details

Sarepta Therapeutics

The Associate II, Nucleoside Manufacturing will focus on support of our Contract Nucleoside Manufacturing sites including oversight of both routine manufacturing and tech transfer of new/improved processes to the sites. Nucleoside manufacturing ensures uninterrupted supply of API and sterile drug product in support of Sarepta’s manufacturing organization. The position is responsible for manufacturing trending, interaction with Sarepta process development and production planning functions, and oversight of manufacturing/project execution with contract manufacturing organizations (CMOs).

Primary Responsibilities Include:
  • Tracking and routing CMO and other vendor document review and approval processes, tracking and archiving project update documents, routing internal reviews to required SMEs
  • Manufacturing trending for process performance and impurity tracking
  • Evaluate post-implementation results after a process change
  • Maintain up to date process trending summary reports
  • Updating existing manufacturing instructions based on changes from CMOs and internal chemistry group
  • Coordinating material shipment and sampling and inventory entry with the Supply-Chain team
  • Marker and standards inventory control and shipment coordination
  • Scheduling meetings with CMOs and vendors for projects
  • Contract processing activities including Purchase Requisition Submission, Purchase Order processing, and invoice tracking
Desired Education and Skills:
  • BA/BS (required) in Chemistry, Chemical Engineering or related scientific discipline
  • Highly-motivated with excellent communication and teamwork skills
  • Ability to work independently, both under supervision and as a contributing team member
  • Able to handle multi-task workload and perform effectively under deadlines
  • 2+ years of experience in the pharmaceutical, or related industry preferred
  • Collaborative interpersonal skills and attention to detail are necessary
  • Position requires infrequent (<5%) domestic and/or international travel
  • Ability to influence cross-functionally and in a remote work environment
  • Experience working with or interacting with people living outside the U.S. is a plus
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 Therapeutics offers a competitive compensation and benefit package
Sarepta Therapeutics is an Equal
Action employer and participates in e-Verify

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