Associate Director, Drug Product Technical Services; DPTS

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities including RNAi silencing and RNA editing provides us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology.

Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington’s disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

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.

• 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

• 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.

• Experience in DP formulation development of liquid and lyophilized presentations including Drug delivery systems and combination products desirable
• 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, Power Point
• Must be self-motivated, able to work independently, and have a proven ability to work in a team environment

Pay…