Associate Director, Drug Product Technical Services (DPTS)

Wave Life Sciences • Lexington, MA

6d

About The Position

The Associate Director of DPTS leads drug product (DP) 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 (DP) 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. The role requires cross-functional influence to progress DPTS deliverables of Wave assets to maintain Wave’s aggressive timelines.

Requirements

• 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
• Strong scientific authoring experience and excellent communication skills required
• Practical knowledge of cGMP regulations required
• Ability to effectively manage time and prioritize tasks independently in a fast-paced environment
• Proficient with MS Office Word, Excel, PowerPoint
• Must be self-motivated, able to work independently, and have a proven ability to work in a team environment

Nice To Haves

• M.S. or Ph. D. degree in Pharmaceutical Sciences, Chemistry or Engineering is preferred OR equivalent work experience
• Experience in Oligonucleotide Manufacturing and Managing CMOs desirable
• Experience with Pre-filled syringes and/or autoinjectors desirable
• Experience in DP formulation development of liquid and lyophilized presentations including Drug delivery systems and combination products desirable

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 and efficient tech-transfer and GMP manufacturing of oligonucleotide adhering to strict quality standards at Wave and CMO sites
• Function as interface/liaison between Process Development, Analytical, Quality, Regulatory and Supply Chain departments
• Supports continuous improvement initiatives by identifying areas needing improvement and communicating strategies for improvement
• Respond quickly and effectively to multiple and changing priorities, and to schedule work effectively to ensure that current and future needs are met
• Technical review of batch records and process instructions internally and externally (CMOs)
• Manage CMO relationships to ensure sufficient Drug Product supply of Wave Assets for clinical and commercial supply.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level