What are the responsibilities and job description for the Senior Director, Quality Control position at Sarepta Therapeutics, Inc.?

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 Senior Director charged with overseeing all internal Quality Control Testing will lead a group of high-functioning QC analysts comprising approximately 50 individuals organized under 3-5 direct reports. The ideal candidate will be highly skilled in managing an integrated testing schedule that supports both a high-throughput late-phase, commercial manufacturing supply chain as well as a dynamic early phase clinical pipeline. The successful candidate will foster a collaborative environment and play a key role in executing the strategy that ensures a continuous global supply of Sarepta's AAV gene therapies for neuromuscular disorders. The candidate will excel in a team-based environment, working closely with Sarepta's Manufacturing, Quality Assurance, and Regulatory Affairs departments. Additionally, the Senior Director will possess superior technical, problem solving, and mentoring skills that facilitate team and individual development.

The Opportunity to Make a Difference

Providing technical leadership and guidance to the internal analytical testing groups.

Ensuring the successful and timely completion of all lot release and stability testing to support all Corporate and Tech Op's business commitments and goals.

Evaluating, reviewing, and approving assay development and qualification reports to ensure smooth and efficient transfer of analytical test methods to the Quality Control group.

Building and managing an appropriate qualification / requalification program to ensure all analysts executing QC testing are fully trained and current on all aspects of their assigned analytical testing areas.

Generating and managing monthly and quarterly metrics (KPIs) to track QC analytical testing performance.

Authoring IND, BLA, NDA, and IMPD sections pertaining to drug product lot release testing for submission to regulatory agencies.

Provide subject matter expertise when engaging in various discussions with external regulatory agencies such as FDA, EMA, and PDMA.

Additionally, proposed expansions to corporate capabilities will require knowledge and experience with Quality Control Microbiology (EM / PM and utilities monitoring) and Quality Control Raw Materials Testing.

More about You

A PhD (or MS with appropriate experience) in Biochemistry, Molecular Biology, or Molecular Virology with twenty years of experience in the pharmaceutical-biologics industry is required.

Additionally, we are looking for an individual with at least fifteen years of experience managing / directing cGMP analytical testing laboratories with a minimum of five to eight years of experience testing and releasing Gene Therapy products (AAV or similar products).

Experience testing and releasing cell therapy products will be considered as appropriate.

A strong technical understanding of molecular virology is required.

Strong technical knowledge in all areas of AAV testing is a must. Areas of expertise must include :

Data Analysis :

Data trending and reporting

Statistical analysis (Strong statistical skills are a must)

General Laboratory - Chemistry Testing :

Osmolality

Visual Inspection

Gravimetric and Volumetric analyses

Particle Analysis : Visible and Sub-visible

Aggregate analyses : SEC and DLS (Dynamic Light Scattering).

Cell Culture and Bioassay Testing :

Aseptic sample handling and aliquoting techniques

Mammalian Cell Culture

Relative Potency Assays (PLA, 4PL / 5PL)

Tissue Culture Infectivity Assays -50% (TCID50)

ELISA and other Protein Binding assays

Nucleic Acid Testing :

Polymerase Chain Reaction : ddPCR, dPCR, qPCR, RT-qPCR

Sequencing : Sanger Sequencing and NGS

Plasmid Manufacturing : Molecular Cloning and Restriction Digestion analysis

Separation Sciences :

Chromatography (LC, LC-MS)

Analytical Ultra Centrifugation (AUC)

Gel Separation Sciences (SDS-PAGE, CE-SDS)

Experience planning and managing budgets in excess of $50 million / year.

Strong written and oral communication skills are a must.

Proven ability to manage projects and work with cross-functional teams comprised of internal and / or external contacts, including CTLs.

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-Onsite

LI-BP1

This position requires work on site at one of Sarepta's facilities in the United States.

The targeted salary range for this position is $216,000 - $270,000 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.

Salary : $216,000 - $270,000

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