Associate Director, Analytical Development - Small Molecule

Responsibilities

• Lead execution of phase-appropriate analytical development strategies in alignment with Director guidance for external partners (CMOs/CROs), ensuring quality, timelines, and alignment with program goals
• Oversee analytical method development, qualification, validation, and transfer activities to support clinical and commercial programs
• Partner cross-functionally and external analytical partners to advance programs, escalating risks and proposing solutions proactively
• Provide technical review and guidance on analytical data, protocols, and reports to ensure scientific rigor and compliance
• Participate in the author and review of analytical sections of regulatory submissions (INDs, NDAs) in collaboration with senior leadership
• Represent the Analytical Development function on various cross-functional project teams including internal project teams as well as third-party analytical and manufacturing teams
• Ensure analytical activities are aligned with regulatory expectations and internal quality standards
• Contribute to continuous improvement initiatives, including processes, workflows, and vendor management practices

Qualifications

• B.S. in chemistry or related discipline with 9+ years of industry or equivalent experience
• Demonstrated small molecule experience in analytical method development and validation as well as associated regulatory requirements
• Experience working in close collaboration with technical, regulatory, quality assurance, project management, and supply chain functions in a cGMP operational environment
• Experience in managing outsourced Analytical Development activities
• Experience in preparing regulatory documents including briefing books for regulatory meetings, INDs, and NDAs
• Excellent communication skills and the ability to present to internal and external audiences
• Strong understanding of cGMP requirements and quality systems related to analytical development activities

Benefits

• Periodic travel to manufacturing and other partner sites (approximately 10% of time)

Pay

• The anticipated annualized base pay range for this full-time position is $183,000 - $223,000

Schedule

• This is a hybrid role (2-3 days in office) at our Waltham, MA headquarters