Associate Director, Drug Product Technical Services (DPTS)

The Associate Director of Drug Product Technical Services leads drug product validation activities for Wave's injectable assets in Phase 1-3 clinical trials and authoring of documents required for Regulatory submissions. This role supports formulation activities to produce viable drug product presentations for phase appropriate clinical studies and manages tech-transfer activities to CMO organizations to ensure sufficient GMP DP supply for clinical trials in conformance with applicable Standard Operating Procedures (SOPs), Wave standards, industry best practices, and regulatory requirements.

Requirements

• M.S. or Ph. D. degree in Pharmaceutical Sciences, Chemistry or Engineering is preferred OR equivalent work experience
• 8+ years Bio-Pharma industry in Aseptic Drug Product GMP environment with PPQ campaign experience required
• Experience of authoring DP sections of CTA/IND/NDA/BLA submissions required
• Experience in Oligonucleotide Manufacturing and Managing CMOs desirable
• Experience with Pre-filled syringes and/or autoinjectors desirable

Benefits

• Company-sponsored medical, dental, vision, life, long and short-term disability insurances
• Generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• 401K participation with matching contributions
• Employee Stock Purchase Program