Associate Director, Drug Product Technical Services (DPTS)
Wave Life Sciences
June 25, 2026
Remote friendly (Greater Boston)
United States
Operations
Description
The Associate Director of DPTS leads drug product (DP) validation activities for Wave’s injectable assets in Phase 1-3 clinical trials and authors documents required for Regulatory submissions. Supports formulation activities to produce viable DP presentations for phase-appropriate clinical studies. Manages tech-transfer activities to CMO organizations to ensure sufficient GMP DP supply for clinical trials in conformance with SOPs, Wave standards, industry best practices, and regulatory requirements. Requires cross-functional influence to progress DPTS deliverables.
Experience / Qualifications
- M.S. or Ph.D. degree in Pharmaceutical Sciences, Chemistry, or Engineering (preferred) or equivalent work experience
- 8+ years in Bio-Pharma industry in an Aseptic Drug Product GMP environment with PPQ campaign experience (required)
- Experience authoring DP sections of CTA/IND/NDA/BLA submissions (required)
- Experience in Oligonucleotide Manufacturing and managing CMOs (desirable)
- Experience with pre-filled syringes and/or autoinjectors (desirable)
Responsibilities
- Plan and execute DP formulation development studies to select phase-appropriate DP presentation
- Initiate/oversee PPQ activities at CMO for commercial readiness for DP
- Author DP sections of regulatory submissions and respond to questions
- Ensure tech-transfer and GMP manufacturing of oligonucleotide at Wave and CMO sites
- Liaison between Process Development, Analytical, Quality, Regulatory, and Supply Chain
- Support continuous improvement initiatives
- Manage multiple/changing priorities and schedules
- Technical review of batch records and process instructions (internal and CMOs)
- Manage CMO relationships to ensure sufficient DP supply for clinical and commercial
Key Skills
- DP formulation development experience (liquid and lyophilized; drug delivery systems/combination products desirable)
- Strong scientific authoring and communication skills (required)
- Practical cGMP knowledge (required)
- Ability to prioritize and work independently in a fast-paced environment
- Proficient with MS Office Word, Excel, PowerPoint
- Self-motivated; proven ability to work in a team environment
The Associate Director of DPTS leads drug product (DP) validation activities for Wave’s injectable assets in Phase 1-3 clinical trials and authors documents required for Regulatory submissions. Supports formulation activities to produce viable DP presentations for phase-appropriate clinical studies. Manages tech-transfer activities to CMO organizations to ensure sufficient GMP DP supply for clinical trials in conformance with SOPs, Wave standards, industry best practices, and regulatory requirements. Requires cross-functional influence to progress DPTS deliverables.
Experience / Qualifications
- M.S. or Ph.D. degree in Pharmaceutical Sciences, Chemistry, or Engineering (preferred) or equivalent work experience
- 8+ years in Bio-Pharma industry in an Aseptic Drug Product GMP environment with PPQ campaign experience (required)
- Experience authoring DP sections of CTA/IND/NDA/BLA submissions (required)
- Experience in Oligonucleotide Manufacturing and managing CMOs (desirable)
- Experience with pre-filled syringes and/or autoinjectors (desirable)
Responsibilities
- Plan and execute DP formulation development studies to select phase-appropriate DP presentation
- Initiate/oversee PPQ activities at CMO for commercial readiness for DP
- Author DP sections of regulatory submissions and respond to questions
- Ensure tech-transfer and GMP manufacturing of oligonucleotide at Wave and CMO sites
- Liaison between Process Development, Analytical, Quality, Regulatory, and Supply Chain
- Support continuous improvement initiatives
- Manage multiple/changing priorities and schedules
- Technical review of batch records and process instructions (internal and CMOs)
- Manage CMO relationships to ensure sufficient DP supply for clinical and commercial
Key Skills
- DP formulation development experience (liquid and lyophilized; drug delivery systems/combination products desirable)
- Strong scientific authoring and communication skills (required)
- Practical cGMP knowledge (required)
- Ability to prioritize and work independently in a fast-paced environment
- Proficient with MS Office Word, Excel, PowerPoint
- Self-motivated; proven ability to work in a team environment