Associate Director, Drug Product Technical Services (DPTS)
Wave Life Sciences
August 07, 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 work to produce phase-appropriate DP presentations and manages tech-transfer activities to CMO organizations to ensure sufficient GMP DP supply for clinical trials in line with SOPs, Wave standards, best practices, and regulatory requirements.
Responsibilities:
- Plan and execute DP formulation development studies to select phase-appropriate DP presentations
- Initiate/oversee PPQ activities at the CMO to ensure DP readiness
- Author DP sections of regulatory submissions and respond to questions
- Ensure effective/efficient tech transfer and GMP manufacturing of oligonucleotides at Wave and CMO sites
- Liaison between Process Development, Analytical, Quality, Regulatory, and Supply Chain
- Support continuous improvement; identify improvements and communicate strategies
- Manage multiple changing priorities and schedules
- Conduct technical review of batch records and process instructions (internal and CMO)
- Manage CMO relationships to ensure sufficient DP supply for clinical/commercial needs
Qualifications/Experience:
- M.S. or Ph.D. in Pharmaceutical Sciences, Chemistry, or Engineering preferred, or equivalent experience
- 8+ years in aseptic drug product GMP environment with PPQ campaign experience required
- Experience authoring DP sections of CTA/IND/NDA/BLA submissions required
- Oligonucleotide manufacturing and CMO management desirable
- Pre-filled syringes and/or autoinjectors experience desirable
Key Skills:
- DP formulation development of liquid and lyophilized presentations (drug delivery systems/combination products desirable)
- Strong scientific authoring and communication skills
- Practical cGMP knowledge
- Strong independent time management and prioritization in a fast-paced environment
- Proficient with MS Office (Word, Excel, PowerPoint)
- Self-motivated; works well independently and in teams
Pay/Benefits (explicitly stated):
- Annual base salary range: $163,000–$221,000
- Discretionary annual bonus and stock-based long-term incentives; comprehensive benefits including company-sponsored insurance, paid time off, 401K 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 required for regulatory submissions. Supports formulation work to produce phase-appropriate DP presentations and manages tech-transfer activities to CMO organizations to ensure sufficient GMP DP supply for clinical trials in line with SOPs, Wave standards, best practices, and regulatory requirements.
Responsibilities:
- Plan and execute DP formulation development studies to select phase-appropriate DP presentations
- Initiate/oversee PPQ activities at the CMO to ensure DP readiness
- Author DP sections of regulatory submissions and respond to questions
- Ensure effective/efficient tech transfer and GMP manufacturing of oligonucleotides at Wave and CMO sites
- Liaison between Process Development, Analytical, Quality, Regulatory, and Supply Chain
- Support continuous improvement; identify improvements and communicate strategies
- Manage multiple changing priorities and schedules
- Conduct technical review of batch records and process instructions (internal and CMO)
- Manage CMO relationships to ensure sufficient DP supply for clinical/commercial needs
Qualifications/Experience:
- M.S. or Ph.D. in Pharmaceutical Sciences, Chemistry, or Engineering preferred, or equivalent experience
- 8+ years in aseptic drug product GMP environment with PPQ campaign experience required
- Experience authoring DP sections of CTA/IND/NDA/BLA submissions required
- Oligonucleotide manufacturing and CMO management desirable
- Pre-filled syringes and/or autoinjectors experience desirable
Key Skills:
- DP formulation development of liquid and lyophilized presentations (drug delivery systems/combination products desirable)
- Strong scientific authoring and communication skills
- Practical cGMP knowledge
- Strong independent time management and prioritization in a fast-paced environment
- Proficient with MS Office (Word, Excel, PowerPoint)
- Self-motivated; works well independently and in teams
Pay/Benefits (explicitly stated):
- Annual base salary range: $163,000–$221,000
- Discretionary annual bonus and stock-based long-term incentives; comprehensive benefits including company-sponsored insurance, paid time off, 401K match, and Employee Stock Purchase Program.