Job DescriptionDescription: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.
Experience:- 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
Responsibilities: May include some or all of the following:
- 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.
Key Skills:- 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, PowerPoint
- Must be self-motivated, able to work independently, and have a proven ability to work in a team environment
Pay Range External Disclosure StatementThe annual base salary range for this position is $163,000 - $221,000
The range provided is based on what we believe is a reasonable estimate for the annual base salary pay range for this position at the time of posting. Actual annual base salary will vary based on several factors including, but not limited to, relevant skills, experience, qualifications, position criticality, and internal equity. This position is eligible for a discretionary annual bonus and discretionary stock-based long-term incentives. In addition to compensation, Wave offers a comprehensive and competitive range of benefits designed to support our employees' and their families physical and financial health and overall well-being. These include, but are not limited to, 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, and Employee Stock Purchase Program.
