Sr Director, Analytical Development
Core
Strategic and technical leadership for analytical development across the pharmaceutical pipeline, ensuring product characterization is fit for regulatory submissions from discovery through commercial.
Role type
Sr Director, Analytical Development
Builds
Robust, scalable commercial testing platforms and analytical control strategies for drug substances and products.
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features (analytical methods & control strategies)
Required skills
Phase-appropriate control strategy development, analytical method development and transfer, cGMP compliance, global regulatory filing support, chromatography (HPLC/UPLC), mass spectrometry, impurity methods, stability testing, method validation, test transfer, technical strategy crafting, complex problem solving under tight timelines.
Preferred skills
Leading diverse scientific organizations, building external vendor/consortia networks, cross-functional governance influence.
Technologies
HPLC, UPLC, Mass Spectrometry
Responsibilities
Lead and develop an organization of scientists accountable for designing and executing science-based analytical strategies; Lead strategic efforts to develop and enhance analytical methods and technologies; Provide leadership in analytical method transfer strategies to internal stakeholders and external CDMOs; Partner with Advanced Characterization to select technologies for critical quality attributes; Manage Module 3 analytical content and data packages for regulatory submissions; Establish and maintain project plans, timelines, budgets, and resource/capacity plans; Lead and develop a diverse organization through hiring, coaching, and succession planning; Represent the function in cross-functional governance forums; Engage with regulatory agencies as an analytical subject-matter expert.
Seniority
Senior, hands-on IC with strategic leadership
