Associate Director, Drug Product Technical Services (DPTS)

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

Job summary

Wave Life Sciences is seeking an Associate Director of DPTS to lead drug product validation activities for injectable assets in Phase 1–3 trials. You will support formulation activities and manage tech-transfer to CMOs to ensure GMP DP supply for clinical studies in line with Wave SOPs and regulatory requirements.

Ideal candidates have 8+ years in Bio-Pharma DP GMP environments, with experience authoring DP sections of CTA/IND/NDA/BLA submissions and familiarity with oligonucleotide

Qualifications

• 8+ years Bio-Pharma experience in an aseptic DP GMP environment with PPQ campaigns.
• Experience authoring DP sections of CTA/IND/NDA/BLA submissions.
• Experience in oligonucleotide manufacturing and managing CMOs desirable.
• Experience with pre-filled syringes and/or autoinjectors desirable.
• PhD or equivalent work experience preferred.

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 tech-transfer and GMP manufacturing of oligonucleotide at Wave and CMO sites.
• Function as liaison between Process Development, Analytical, Quality, Regulatory and Supply Chain departments.
• Support continuous improvement initiatives by identifying areas needing improvement and communicating strategies.
• Respond quickly to changing priorities and schedule work to meet needs.
• Technical review of batch records and process instructions (internal and external CMOs).
• Manage CMO relationships to ensure DP supply for clinical and commercial use.

Skills

Strong scientific writing

cGMP knowledge

Time management

Team collaboration

MS Office (Word, Excel, PowerPoint)

Independent work

Education

PhD or equivalent in Pharmaceutical Sciences, Chemistry or Engineering

Equivalent work experience

Tools

Pre-filled syringes

Autoinjectors

Job description

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.

Description

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

• 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

• 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 questionsEnsure 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 Disclosure Statement: $163,000 USD - $221,000 USD

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. Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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