Associate Director, Drug Product Validation & Tech-Transfer

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 drug product validation activities for injectable assets in Phase 1–3 trials. You will support formulation activities and manage tech-transfer to CMOs to ensure GMP DP supply for clinical studies in line with Wave SOPs and regulatory requirements.

Ideal candidates have 8+ years in Bio-Pharma DP GMP environments, with experience authoring DP sections of CTA/IND/NDA/BLA submissions and familiarity with oligonucleotide

Qualifications

• 8+ years Bio-Pharma experience in an aseptic DP GMP environment with PPQ campaigns.
• Experience authoring DP sections of CTA/IND/NDA/BLA submissions.
• Experience in oligonucleotide manufacturing and managing CMOs desirable.
• Experience with pre-filled syringes and/or autoinjectors desirable.
• PhD or equivalent work experience preferred.

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 their questions. Ensure effective tech-transfer and GMP manufacturing of oligonucleotide at Wave and CMO sites.
• Function as liaison between Process Development, Analytical, Quality, Regulatory and Supply Chain departments.
• Support continuous improvement initiatives by identifying areas needing improvement and communicating strategies.
• Respond quickly to changing priorities and schedule work to meet needs.
• Technical review of batch records and process instructions (internal and external CMOs).
• Manage CMO relationships to ensure DP supply for clinical and commercial use.

Skills

Strong scientific writing

cGMP knowledge

Time management

Team collaboration

MS Office (Word, Excel, PowerPoint)

Independent work

Education

PhD or equivalent in Pharmaceutical Sciences, Chemistry or Engineering

Equivalent work experience

Tools

Pre-filled syringes

Autoinjectors

Job description

Wave Life Sciences is seeking an Associate Director of DPTS to lead drug product validation activities for injectable assets in Phase 1–3 trials. You will support formulation activities and manage tech-transfer to CMOs to ensure GMP DP supply for clinical studies in line with Wave SOPs and regulatory requirements.

Ideal candidates have 8+ years in Bio-Pharma DP GMP environments, with experience authoring DP sections of CTA/IND/NDA/BLA submissions and familiarity with oligonucleotide