Senior Director, Analytical Development, Separation Science and Protein Chemistry

Why Sarepta Why Now

The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle central nervous system and cardiac 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were 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: Importance of the Role

The Senior Director will oversee the development of HPLC and Mass spectrometry based analytical methods for RNA (Phosphorodiamidate Morpholino Oligomer and Silencing RNA) Drug substance Drug Product including in-process release and stability testing. The individual will direct and manage the activities related to mass spectrometry based protein analysis for the AAV based product line and ADC (siRNA) programs. The person would oversee the activities in developing purity and impurity characterization methods and excipient analysis.
This role will represent Analytical Development in high level internal meetings and coordinate method transfers to internal QC laboratories and external GMP testing sites. The Senior Director will oversee the creation of protocols for freezethaw studies accelerated degradation studies and method qualification and validation in collaboration with the Sarepta Head of Quality Control or their designee. They will also support troubleshooting of analytical methods at CROs/CTOs and may facilitate the transfer of complex analytical assays into Sareptas GMP laboratories.

Additionally the Senior Director will lead the writing and compilation of regulatory documents to support product development and registration.

The Opportunity to Make a Difference

• Manage a team of scientists to efficiently deliver on corporate goals and project timelines.
• Evaluate analytical methods to support inprocess drug substance drug product and stability testing across the siRNA PMO and AAV portfolios.
• Act as a company liaison with contract laboratories coordinating method transfers and overseeing method qualification and validation activities.
• Assess QC needs and generate essential testing documentation including SOPs change controls laboratory investigations outofspecification (OOS) investigations deviations and QC trending reports for testing results and assay performance.
• Collaborate with Quality Assurance to prepare review and manage change controls deviations and other quality event documentation.
• Write and edit regulatory documents including eCTD sections for IND NDA and BLA submissions.
• Demonstrate strong leadership and managerial capabilities supervising a team of 510 Analytical Development analysts both onsite and remote.
• Ensure laboratory operations supporting product release activities comply with cGMP standards.

More about You

• MS in Biology Chemistry Molecular Biology or a related discipline with 15 years of relevant experience or PhD in Biology Chemistry Molecular Biology or a related field with 10 years of relevant experience or an equivalent combination of education and laboratory experience.
• 10 years of experience in analytical method development including advanced expertise in HPLC/UPLC and mass spectrometrybased methods.
• Exceptional written and verbal communication skills with the ability to clearly convey complex scientific and regulatory concepts.
• Experience representing organizations in regulatory interactions including facetoface meetings preapproval inspections (PAIs) and preparation of written responses across a global regulatory portfolio.
• Demonstrated product lifecycle management experience across clinical and commercial stages.
• Strong collaboration and teamwork skills with the ability to support crossfunctional peers and maintain a safe efficient and compliant laboratory environment.
• Experience working with contract laboratories and external vendors (CROs/CMOs) is highly desirable.
• Ability to travel approximately 15%.

What Now

Were always looking for solution-oriented critical thinkers.

So if youre 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-Onsite

#LI-ES1

This position requires work on site at one of Sareptas facilities in the United States.

The targeted salary range for this position is $222400 - $278000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas 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.