Associate Director, Clinical Supply Chain Engineer

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

Youll design and develop a robust clinical supply chain that enables timely compliant and efficient delivery of investigational products worldwide.

The Opportunity to Make a Difference

The Importance of the Role

The Associate Director Clinical Supply Chain Engineer will play a critical role in ensuring the success of global clinical trials across multiple phases of development. Youll design and develop a robust clinical supply chain that enables timely compliant and efficient delivery of investigational products worldwide. This position requires strong process development and project management skills to translate clinical program requirements into robust operations. Additionally you will work closely with strategic partners and CMOs to execute on agreed upon timelines and plans. The position will also be responsible for managing KPI/dashboards and for ensuring that issues are escalated and key deliverables are progressed.

The Opportunity to Make a Difference

• Participate in Clinical Trial Teams and Transition Teams to gather critical information in order to design develop and implement robust clinical drug supply operations.
• Analyze and improve end-to-end clinical supply chain processes including packaging labeling distribution returns and reconciliation.
• Facilitate cross-departmental meetings to ensure alignment identify dependencies and resolve integration challenges.
• Collaborate with functional leaders to harmonize processes systems and documentation for the partnered & acquired assets.
• Partner with Manufacturing Quality Regulatory and Clinical Operations to ensure clinical material availability aligns with study timelines and compliance requirements.
• Evaluate depot site and packaging network flows to optimize inventory positioning and shipment strategies including temperature-controlled and time-sensitive materials.
• Lead continuous improvement initiatives focused on process standardization error prevention and operational scalability.
• Responsible for process mapping and evaluating capacity planning workflow design and continuous improvement utilizing methodologies such as Lean or Six Sigma.
• Support investigations root cause analysis and corrective/preventive actions related to supply chain deviations or performance gaps.
• Manage projects with CMOs

More about You

More about You

• BS in industrial engineering or equivalent with 10 years of experience in a Pharmaceutical Operations organization and 3 years of experience with clinical supply
• Certification in Lean Six Sigma APICS/ASCM or related disciplines
• Experience with process optimization data analysis quality and efficiency
• Familiarity with GMP GDP and clinical trial supply requirements in regulated environments.
• Experience working with CROs CMOs and third-party vendors
• Proficiency with quality systems including developing policies SOPs and work instructions
• Excellent communication problem-solving and cross-functional collaboration skills.
• Ability to travel domestically and internationally.

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-Hybrid

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This position is hybrid you will be expected to work on site at one of Sareptas facilities in the United States and/or attend Company-sponsored in-person events from time to time.

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.