Senior Director, Quality Control

Sarepta Therapeutics; Andover (MA); On-site; USD 216,000 - 270,000; Full time

Job summary

Join a pioneering company at the forefront of genetic medicine as a Senior Director of Quality Control. This role involves overseeing a dedicated team responsible for ensuring the quality of life-saving therapies. You will provide technical leadership, manage complex testing schedules, and collaborate with cross-functional teams to support both commercial and clinical pipelines. With a commitment to innovation and patient care, this position offers a unique opportunity to make a significant impact in the field of neuromuscular disorders. If you are a strategic thinker with a passion for science and leadership, this is the perfect opportunity for you.

Benefits

Competitive Compensation

Health and Wellness Programs

Work-Life Integration Resources

Financial Wellness Support

Qualifications

• 20 years in pharmaceutical-biologics, with 15 years in cGMP analytical testing.
• Strong technical understanding of molecular virology and AAV testing.

Responsibilities

• Lead internal Quality Control Testing with a team of 50 QC analysts.
• Ensure timely completion of lot release and stability testing.

Skills

Project Management

Statistical Analysis

Technical Leadership

Communication Skills

Problem Solving

Education

PhD in Biochemistry, Molecular Biology, or Molecular Virology

MS with appropriate experience

Tools

Chromatography

Polymerase Chain Reaction

Statistical Software

Job description

Senior Director, Quality Control

Senior Director, Quality Control

Apply remote type Onsite locations Andover, MA time type Full time posted on Posted Yesterday job requisition id R-02794

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:

1. Physical and Emotional Wellness
2. Financial Wellness
3. Support for Caregivers

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

1. Providing technical leadership and guidance to the internal analytical testing groups.
2. 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.
3. Evaluating, reviewing, and approving assay development and qualification reports to ensure smooth and efficient transfer of analytical test methods to the Quality Control group.
4. 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.
5. Generating and managing monthly and quarterly metrics (KPIs) to track QC analytical testing performance.
6. Authoring IND, BLA, NDA, and IMPD sections pertaining to drug product lot release testing for submission to regulatory agencies.
7. Provide subject matter expertise when engaging in various discussions with external regulatory agencies such as FDA, EMA, and PDMA.
8. 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

1. 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.
2. 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).
3. Experience testing and releasing cell therapy products will be considered as appropriate.
4. A strong technical understanding of molecular virology is required.
5. Strong technical knowledge in all areas of AAV testing is a must. Areas of expertise must include:
1. Data Analysis:
   1. Data trending and reporting
   2. Statistical analysis (Strong statistical skills are a must)
2. General Laboratory – Chemistry Testing:
   1. pH
   2. Osmolality
   3. Visual Inspection
   4. Gravimetric and Volumetric analyses
   5. Particle Analysis: Visible and Sub-visible
   6. Aggregate analyses: SEC and DLS (Dynamic Light Scattering).
3. Cell Culture and Bioassay Testing:
   1. Aseptic sample handling and aliquoting techniques
   2. Mammalian Cell Culture
   3. Relative Potency Assays (PLA, 4PL/5PL)
   4. Tissue Culture Infectivity Assays -50% (TCID50)
   5. ELISA and other Protein Binding assays
4. Nucleic Acid Testing:
   1. Polymerase Chain Reaction: ddPCR, dPCR, qPCR, RT-qPCR
   2. Sequencing: Sanger Sequencing and NGS
   3. Plasmid Manufacturing: Molecular Cloning and Restriction Digestion analysis
5. Separation Sciences:
   1. Chromatography (LC, LC-MS)
   2. Analytical Ultra Centrifugation (AUC)
   3. Gel Separation Sciences (SDS-PAGE, CE-SDS)
6. Experience planning and managing budgets in excess of $50 million/year.
7. Strong written and oral communication skills are a must.
8. 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.

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.

About Us

Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. 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. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing.