Role: Associate Director, Analytical Development leading in-house lab operations supporting PepGen's pipeline of neuromuscular disorder therapies.
Responsibilities
- manage and optimize analytical methods development and validation (e.g., UHPLC-TOF, UHPLC-MS/MS) for peptides, oligos, and proprietary enhanced delivery oligonucleotides
- oversee characterization activities, impurity profiling, and CQA assessments
- lead extended characterization, comparability strategies, and regulatory documentation
- manage external contract labs
- mentor team members and foster cross-functional collaboration
Requirements
- Ph.D. in Chemistry or related field with 5+ years’ (Ph.D.) or 8+ years’ (Master’s) experience in analytical development
- expertise in peptides, oligonucleotides, and conjugates
- proven leadership in CQA and regulatory submissions
- strong knowledge of chromatographic techniques, ICH/USP guidelines, cGMPs, and analytical validation
HighValue: biologics/oligos, drug discovery and development, analytical method validation, impurity characterization, regulatory filing support, cross-functional collaboration, team leadership.
WorkSetup: not specified; likely hybrid or onsite with potential for travel.
#J-18808-LjbffrAssociate Director, Analytical Development in boston at Unknown Company
This position is listed as contract and hybrid.