Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
 

We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
 

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

Physical and Emotional Wellness

​Financial Wellness

Support for Caregivers
 

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
 

The Importance of the Role

The Manager, Drug Product Manufacturing Science & Technology will support the technical, process development and production of parenteral drug products at external contract manufacturing organizations for Sarepta’s Gene therapy & RNA programs. The candidate will partner with CMOs and internal groups to establish robust technical relationships related to the development and manufacturing of drug products. The candidate will be responsible for the development and technology transfer of manufacturing processes, as well as providing day to day support for GMP manufacturing. This position will provide expertise in the areas of process development, validation, aseptic fill/finish, lyo development, product life cycle management, technology transfer, primary packaging, visual inspection and process analytics.

The Opportunity to Make a Difference

Lead/support tech transfer projects to external vendors for commercial and clinical programsAct as technical SME to support commercial drug product manufacturing at external contract manufacturing (CMO) organizationsAuthor and manage change controls, CAPAs, and investigations related to drug product manufacturingWork directly with external contract manufacturing (CMO) organizations to develop robust manufacturing processes/systemsWork with CMOs and external OEMs to develop process control strategiesPartner with analytical development, QC, and QA groups to progress key development activitiesLead cross functional teams to support clinical and commercial drug product activitiesAuthor and review CMC regulatory submission documents for clinical and commercial productsDevelop the continued process verification (CPV) program for commercial parenteral drug product manufacturing products

More about You

B.S./M.S. in chemical/biochemical engineering, pharmaceutical sciences, or organic/physical/analytical chemistry, with 5+ yrs. experienceThis role requires a minimum of 5 years experience in sterile drug product process development, continued process verification, technology transfer, validation and GMP manufacturingExperience developing and managing technical relationships with external contract manufacturing organizations Expertise in GMP facilities and equipment design/engineering conceptsWell-developed understanding of formulation approachesExperience in leading cross functional teams to deliver keys projectsExperience with risk assessments and risk-based decision makingExperience with regulations and requirements such as cGMP, ICH, USP, JPExperience with statistical software for the purpose of managing CPVDomestic and international travel required

What Now?

We’re always looking for solution-oriented, critical thinkers.

So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
 

#LI-Hybrid

#LI-TD1

This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $112,000 - $140,000 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.