Associate Director, Drug Product Technical Services (DPTS)
Wave Life Sciences
August 29, 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 for regulatory submissions. Supports formulation activities to produce phase-appropriate DP presentations for clinical studies and manages tech-transfer to CMO organizations to ensure sufficient GMP DP supply for clinical trials in line with SOPs, Wave standards, best practices, and regulatory requirements. Works cross-functionally to progress DPTS deliverables and timelines.
Experience / Qualifications:
- M.S. or Ph.D. in Pharmaceutical Sciences, Chemistry, or Engineering (preferred) or equivalent experience
- 8+ years in aseptic Bio-Pharma DP GMP environment with PPQ campaign experience (required)
- Authoring DP sections of CTA/IND/NDA/BLA submissions (required)
- Oligonucleotide manufacturing and CMO management (desirable)
- Experience with pre-filled syringes and/or autoinjectors (desirable)
Responsibilities:
- Plan and execute DP formulation development to select phase-appropriate DP presentation
- Initiate/oversee PPQ at CMOs to ensure commercial readiness
- Author DP sections of regulatory submissions and respond to questions
- Ensure tech-transfer and GMP oligonucleotide manufacturing quality at Wave and CMO sites
- Liaison between Process Development, Analytical, Quality, Regulatory, and Supply Chain
- Support continuous improvement
- Prioritize and respond to changing priorities
- Technical review of batch records and process instructions (internal/external)
- Manage CMO relationships to ensure DP supply for clinical and commercial needs
Key Skills:
- Liquid and lyophilized DP formulation development experience (desirable)
- Strong scientific authoring and communication skills (required)
- Practical cGMP knowledge (required)
- Time management/prioritization in fast-paced environments
- Proficiency with MS Office (Word, Excel, PowerPoint)
- Self-motivated, independent, and team-oriented
Pay/Benefits (explicitly stated):
- Base salary: $163,000–$221,000 annually
- Discretionary annual bonus and stock-based long-term incentives
- Comprehensive benefits incl. medical/dental/vision, life, disability, paid time off, 401(k) match, and Employee Stock Purchase Program
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 for regulatory submissions. Supports formulation activities to produce phase-appropriate DP presentations for clinical studies and manages tech-transfer to CMO organizations to ensure sufficient GMP DP supply for clinical trials in line with SOPs, Wave standards, best practices, and regulatory requirements. Works cross-functionally to progress DPTS deliverables and timelines.
Experience / Qualifications:
- M.S. or Ph.D. in Pharmaceutical Sciences, Chemistry, or Engineering (preferred) or equivalent experience
- 8+ years in aseptic Bio-Pharma DP GMP environment with PPQ campaign experience (required)
- Authoring DP sections of CTA/IND/NDA/BLA submissions (required)
- Oligonucleotide manufacturing and CMO management (desirable)
- Experience with pre-filled syringes and/or autoinjectors (desirable)
Responsibilities:
- Plan and execute DP formulation development to select phase-appropriate DP presentation
- Initiate/oversee PPQ at CMOs to ensure commercial readiness
- Author DP sections of regulatory submissions and respond to questions
- Ensure tech-transfer and GMP oligonucleotide manufacturing quality at Wave and CMO sites
- Liaison between Process Development, Analytical, Quality, Regulatory, and Supply Chain
- Support continuous improvement
- Prioritize and respond to changing priorities
- Technical review of batch records and process instructions (internal/external)
- Manage CMO relationships to ensure DP supply for clinical and commercial needs
Key Skills:
- Liquid and lyophilized DP formulation development experience (desirable)
- Strong scientific authoring and communication skills (required)
- Practical cGMP knowledge (required)
- Time management/prioritization in fast-paced environments
- Proficiency with MS Office (Word, Excel, PowerPoint)
- Self-motivated, independent, and team-oriented
Pay/Benefits (explicitly stated):
- Base salary: $163,000–$221,000 annually
- Discretionary annual bonus and stock-based long-term incentives
- Comprehensive benefits incl. medical/dental/vision, life, disability, paid time off, 401(k) match, and Employee Stock Purchase Program