Manager, Drug Product Development

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 Opportunity to Make a Difference

• Conducts product characterization and formulation development experiments internally, and externally at contract testing laboratories and manufacturing sites to support development of the drug product process.
• Participates and/or manages tech transfer of new processes to CMOs including change controls, manufacturing documentation and batch record development, risk assessments, troubleshooting, and process validation.
• Works closely with Quality Control, Analytical Development, and other stakeholders to develop appropriate, well-characterized formulations, identify impurities via method development, and establish specifications.
• Participates across the Tech Ops organization to support internal drug product development laboratory capabilities at Sarepta's Burlington and Andover, MA sites.
• Performs feasibility assessments of new state of the art laboratory techniques and technology concepts and is responsible for understanding and deploying them in house or at external sites to solve novel problems.
• Contributes and/or leads studies internally and externally to support process development including formulation development, product characterization, container closure qualification, extractable and leachable analysis, filter validation, and developing design of experiments.
• Acts as a group liaison across various Contract Manufacturing Organization (CMO) and Contract Research Organization (CRO) sites.
• Supports authoring and reviewing of CMC regulatory submission documents for clinical and commercial products.

More about You

• 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 manufacturing and testing organizations.
• Experience working with and characterizing gene therapies is preferred.

• Ability and willingness to work in a laboratory setting is a must.
• Excellent verbal, written, and interpersonal communication skills are a must.
• B.S. with 6-8 years of experience or M.S. with 3-5 years of experience in chemical/biochemical engineering, pharmaceutical sciences, or organic/physical/analytical chemistry, with at least 3+ yrs. experience in sterile drug product process development.
• Understanding of formulation approaches to develop liquid, frozen 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.
• Willingness to learn new techniques and strategies to support drug product development capabilities.
• Position may require some travel (<10%).

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.