Associate Director, Drug Product Technical Services (DPTS)

Role: Associate Director of DPTS overseeing drug product validation for Wave's injectable assets in Phase 1-3 clinical trials. Primary objectives include ensuring GMP compliance, managing formulation activities, and authoring regulatory documentation. Responsibilities: plan and execute DP formulation development, oversee tech transfer to CMO, author regulatory submission sections, manage CMO relationships, and support continuous process improvements. Qualifications: Ph.D. or Master’s in Pharmaceutical Sciences, Chemistry, or Engineering preferred; 8+ years in biopharma GMP environment with experience in aseptic drug product manufacturing, PPQ campaigns, and regulatory submissions, particularly for oligonucleotide therapies. Desirable skills include experience with pre-filled syringes, autoinjectors, and combination products. High-Value: focus on RNA oligonucleotide-based therapeutics, Phase 1-3 clinical trials, GMP manufacturing, and regulatory documentation. Collaboration with Process Development, Analytical, Quality, Regulatory, and Supply Chain teams. Work setup: not specified; likely hybrid or on-site based on industry norms.