Associate Director, Drug Product Tech & Validation

Wave Life Sciences; Lexington (MA); On-site; USD 163,000 - 221,000; Full time

Job summary

Wave Life Sciences is seeking an Associate Director of DPTS to lead DP validation activities for injectable assets in clinical trials and to manage tech-transfer to CMOs for GMP DP supply. The role requires cross-functional influence to keep aggressive timelines and regulatory readiness.

The position calls for a PhD or equivalent experience with extensive DP GMP/PPQ exposure, authoring regulatory sections, and strong communication across Development, Regulatory, and QA teams.

Qualifications

• PhD or MSc in Pharmaceutical Sciences, Chemistry or Engineering preferred or equivalent experience.
• 8+ years in Bio-Pharma with PPQ campaign experience in aseptic DP GMP environment.
• Experience authoring DP sections of CTA/IND/NDA/BLA submissions required.

Responsibilities

• Plan and execute DP formulation development studies to select Phase appropriate DP presentation.
• Initiate/Oversee PPQ activities at CMO ensuring commercial readiness for DP.
• Author DP sections of Regulatory submissions and provide timely responses to questions.
• Ensure effective tech-transfer and GMP manufacturing of oligonucleotide at Wave and CMO sites.
• Interface between Process Development, Analytical, Quality, Regulatory and Supply Chain.

Skills

DP formulation

GMP experience

Regulatory writing

Project management

Communication

cGMP knowledge

Teamwork

Education

PhD or MSc in Pharmaceutical Sciences/Chemistry/Engineering

Tools

CMO management

Regulatory submissions

PPQ coordination

Job description

Wave Life Sciences is seeking an Associate Director of DPTS to lead DP validation activities for injectable assets in clinical trials and to manage tech-transfer to CMOs for GMP DP supply. The role requires cross-functional influence to keep aggressive timelines and regulatory readiness.

The position calls for a PhD or equivalent experience with extensive DP GMP/PPQ exposure, authoring regulatory sections, and strong communication across Development, Regulatory, and QA teams.