Senior Director, Drug Substance Expert

5 days ago


Étreux, Hauts-de-France, United States PepGen Full time

About the Role

We are seeking a highly experienced Senior Director to lead our drug substance team in development and manufacturing as part of PepGen's CMC team. This individual will manage the drug substance needs of our growing pipeline and be responsible for preparing regulatory filings.

Key Responsibilities:

  • Develop and execute long-range DS development plans to advance our pipeline toward validation and commercialization.
  • Manage scientists and lead the DS team across the pipeline to support preclinical and early clinical programs, as well as late-stage drugs.
  • Review and approve drug substance development protocols, MBRs, production records, and testing results.
  • Collaborate with the PepGen CMC team to strategically drive the strategy for peptides and oligos according to project goals and development stage.
  • Contribute to day-to-day activities, including timeline and budget management, and objective setting in a thriving and growing drug substance group.
  • Collaborate with CMOs and other external partners and assess opportunities stateside and in Europe + Asia.

Requirements:

  • Requires an advanced degree in Pharmaceutical Sciences, Chemistry, Materials Science, or related field with 5+ years of experience in process development and manufacturing of peptide and oligonucleotide APIs, including PMOs.
  • Experience with solid phase peptide/oligo synthesis is preferred.
  • Experience working in a cGMP environment is required.

About PepGen

PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases.

The ideal candidate will have strong leadership skills, planning, and organizational capabilities, and be able to implement work plans cross-functionally. The salary for this role is estimated to be around $180,000 - $220,000 per year, based on location and industry standards.

This is not a remote role, and we operate in a hybrid model in office Tues, Weds & Thurs each week. We are an Equal Opportunity Employer committed to a culturally diverse workforce.



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