Associate Director, Drug Product Technical Services (DPTS)

Lead drug product validation activities for Wave’s injectable assets in Phase 1-3 clinical trials and author regulatory submission documents. Support formulation activities to produce viable DP presentations for phase-appropriate studies and manage tech-transfer to CMOs to ensure GMP DP supply for clinical trials in conformance with SOPs and Wave standards. Require cross-functional influence to progress DP deliverables and maintain aggressive timelines. Plan and execute DP formulation development studies, initiate/oversee PPQ activities at CMOs, author DP sections of regulatory submissions, ensure GMP manufacturing of oligonucleotides at Wave and CMOs, and serve as the interface between Process Development, Analytical, Quality, Regulatory, and Supply Chain. Strong scientific authoring, communication skills, and a solid understanding of cGMP regulations are essential, with the ability to work independently and within a team in a fast-paced environment. The role may include responsibilities related to process development, technical review of batch records, and management of relationships with CMOs to ensure DP supply for clinical and commercial use. The position offers a base salary range of $163,000-$221,000 with potential discretionary annual bonus and stock-based incentives, plus comprehensive benefits. The posting notes a commitment to equal employment opportunity.