Description
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. PepGen’s Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases
Position Summary
Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team. This person will manage the drug substance needs of PepGen’s growing pipeline. In addition, this position will be required to actively support the preparation of regulatory filings. Technical collaboration and integrated planning with PepGen’s internal CMC team and associated CMO/CRO organizations are key success factors, along with expert leadership for the completion of planned activities in accordance with agreed scope, timing, and budget. The ideal candidate will thrive in a fast paced, high growth organization.
Responsibilities
- Support the development of the Drug Substance strategy and oversee manufacturing of preclinical and clinical material.
- Build and execute long range DS development plans to advance PepGen’s pipeline toward validation and commercial.
- 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, MBR's, production records, and testing results.
- Work 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, 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 and oversee routine manufacturing as a PepGen representative (Person in Plant).
- Assist in negotiation of third-party contracts.
- Demonstrate prototypical leadership skills, planning, and organizational capabilities.
- Implement work plans cross functionally.
- Manage all logistical issues including inventory of DS and intermediates.
- Assist with laboratory investigations and the review of investigation reports.
Qualifications and Experience
- 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 preferred.
- Experience working in a cGMP environment required.
- Experience with chimeric peptide/oligo APIs a plus.
- Experience with lyophilized APIs a plus.
- Available to travel if/when needed.