Associate Director, Drug Product Validation & Tech Transfer

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

Benefits offered by this job

Discretionary annual bonus

Comprehensive benefits package

401(k) with matching contributions

Employee Stock Purchase Program

Job summary

Wave Life Sciences is looking for an Associate Director for the Drug Product Team to lead validation activities for injectable assets. This role will manage GMP supply, oversee regulatory submissions, and ensure effective tech-transfer for clinical trials. Candidates should have a strong background in Bio-Pharma, particularly in drug product formulation and should hold a relevant master’s or doctorate degree. The position includes a competitive salary and benefits package.

Qualifications

• 8+ years in Bio-Pharma industry with PPQ campaign experience.
• Experience authoring DP sections of CTA/IND/NDA/BLA submissions.
• Experience with pre-filled syringes and/or autoinjectors desirable.

Responsibilities

• Plan and execute DP formulation development studies.
• Initiate PPQ activities at CMOs for commercial readiness.
• Ensure effective tech-transfer and GMP manufacturing of oligonucleotides.
• Manage CMO relationships to ensure sufficient DP supply.
• Support continuous improvement initiatives.

Skills

Aseptic Drug Product GMP environment

Regulatory submissions

Oligonucleotide Manufacturing

Technical communication

Time management

Education

M.S. or Ph.D. in Pharmaceutical Sciences, Chemistry or Engineering

Tools

MS Office (Word, Excel, PowerPoint)

Job description

Wave Life Sciences is looking for an Associate Director for the Drug Product Team to lead validation activities for injectable assets. This role will manage GMP supply, oversee regulatory submissions, and ensure effective tech-transfer for clinical trials. Candidates should have a strong background in Bio-Pharma, particularly in drug product formulation and should hold a relevant master’s or doctorate degree. The position includes a competitive salary and benefits package.