Sonya S.

About Sonya S.

With over 25 years of experience in cGMP drug product manufacturing, I am a senior manager drug product operations at Sarepta Therapeutics, a leading biotechnology company focused on developing innovative therapies for rare diseases. My mission is to ensure the timely and quality delivery of clinical and commercial drug products to patients in need, using contractual agreements with external vendors and applying best practices in aseptic processing and fill finish.I have a proven track record of developing, scaling up and improving manufacturing processes for various modalities, including mRNA, cell and gene therapy, and pharmaceuticals. I have led technology transfer projects, reduced processing time and costs, increased output and efficiency, and eliminated contamination risks. I have also built, developed, and led high-performing teams of operators across multiple shifts and sites. I am always eager to learn new skills and technologies and connect with other field professionals. You can reach me at s••••••••@gmail.com.

Experience

1. Senior Manager Drug Product Operations - External Mfg

   Sarepta Therapeutics

   Jul 2023 — Present · Frederick, MD, US

   Oversee late-stage clinical and commercial sterile drug product operations across external contract manufacturers for both gene therapy and RNA programs.• Partner with cross-functional teams, including Global Supply Chain, QA/QC, Regulatory Affairs, and CMC, to optimize external supplier relationships, evaluate new partnerships, and implement process improvements.• Manage contractual agreements with Gene Therapy and RNA drug product vendors to ensure clinical and commercial supply continuity.• Drive production readiness activities, ensuring timely drug delivery by overseeing batch records, validation protocols, and supporting technical documentation.• Monitor vendor performance and enforce corrective actions to maintain on-time commercial drug product delivery.• Mitigate supply chain risks by proactively escalating potential disruptions and strategizing inventory management.• Lead contract negotiations, solicit competitive bids, and establish favorable terms with external suppliers to align with business objectives.• Spearhead operational strategies to minimize disruptions due to regulatory updates, leveraging analytics and trend modeling to enhance efficiency.• Represent the organization in business review meetings with suppliers, supporting Joint Steering Committee discussions to ensure operational excellence.• Drive harmonization efforts across the drug product network, streamlining best practices to improve overall manufacturing and supply operations.

Education

• University of Tennessee-Health Science Center College of Medicine

  Postgraduate certificate, Tablet Technology

• Drexel University College of Medicine

  Master’s Degree (MS), Clinical Research

• Rider University

  Bachelor of Arts (B.A.), Liberal Arts and Sciences/Liberal Studies

• Jersey Tractor Trailer Driving School

  CDL Class A with endorsements - Tanker, Hazmat, Doubles Triples, Tractor Trailer

  2014 — 2014

• Columbia Presbyterian Medical Center

  Lab. Technology Internship, Chemistry