• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

The Lead Engineer, Quality Validation will be responsible for providing quality and technical support for qualification and validation activities related to analytical methods for both internal customers and CMOs/CTLs. The individual will support and facilitate the development of project plans, qualification protocols and reports for all stages of the qualification process.

• Provide quality oversight for transfer of analytical methods
• Provide quality oversight for method verification/qualification/validation protocol, exception, and report reviews
• Adhere to regulatory guidance, policies, and procedures for qualification and validation of analytical methods
• Independently coordinate and directly interface with multiple departments both internally and with our contract manufacturing and testing organizations
• Use risk management principles for qualification and remediation efforts
• Provide regular updates directly to Management

• 8-12 years of relevant experience and bachelor’s degree in science or related field. Biopharmaceutical or Pharmaceutical experience preferred
• Direct experience in analytical method qualification and validation using FDA, USP and ICH guidance required.
• Experience with method development, qualification and/or validation for clinical and commercial in-process and release testing required
• Must have in-depth understanding and application of GMP and validation principles, concepts, practices and standards in the US and internationally
• Knowledge of biologics/gene therapy processes desirable
• Able to execute complex concepts, techniques, and standards and new applications based on quality principles and theories
• Able to implement solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness
• Demonstrates knowledge of industry best practices and trends
• Excellent verbal, written, and interpersonal communication skills are required

#LI-Hybrid #LI-ES1 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.