Job Summary
This Sr. Director of Analytical Development (AD) provides strategic and technical leadership for analytical development across the pipeline, from discovery through marketing approval and product lifecycle management. The leader drives the development and execution of end‑to‑end, phase‑appropriate analytical control, method development, and transfer strategies—from raw materials through drug product—ensuring product characterization is fit for regulatory submissions. Recognized for scientific expertise and leadership, the leader builds and develops high‑performing teams, manages budgets and resources, and partners closely with Technical Development, Regulatory Affairs, Quality, Manufacturing, and external partners and contract laboratories to advance the pipeline.
Responsibilities
- Lead and develop an organization, from Directors to Research Associates, accountable for designing and executing science‑based, phase‑appropriate analytical strategies spanning raw materials through drug product to advance pipeline programs in alignment with clinical development plans, business objectives, and regulatory expectations.
- Lead strategic efforts to develop and continuously enhance analytical methods and technologies, translating innovation into robust, scalable commercial testing platforms.
- Provide leadership in analytical method transfer strategies to internal stakeholders, including Quality Control, as well as external CDMOs or CTLs.
- Provide strategic leadership for characterization of raw material, intermediate, drug substance, and drug product, partnering closely with the Advanced Characterization subfunction to select and apply fit‑for‑purpose technologies that enable robust assignment of critical quality attributes.
- Partner with the Advanced Analytical Technology subfunction to define and execute the AD technology roadmap and drive phase‑appropriate deployment of innovative technologies that modernize control strategies, accelerate development, improve quality, and enable next‑generation manufacturing and analytical testing.
- Manage Module 3 analytical content and data packages in collaboration with CMC Regulatory Affairs for IND/CTA, NDA/MAA/BLA and lifecycle submissions, including responses to health authority questions.
- Establish and maintain project plans, timelines, budgets, and resource/capacity plans; manage headcount assignments by program and proactively identify/escalate delivery risks.
- Provide technical leadership aligned with industry standards and global regulatory guidance; make critical scientific decisions to meet changing business needs.
- Lead and develop a diverse organization of scientists and leaders through hiring, coaching, performance management, succession planning, and talent development.
- Represent the function in cross-functional governance and leadership forums; build strong alliances with Drug Substance, Drug Product, Regulatory, Quality, Manufacturing, and external partners/CMOs/CTLs.
- Ensure compliance with applicable corporate policies, procedures, and quality systems, including cGMP expectations.
- Foster an innovative, inclusive, and execution-focused environment while maintaining high scientific standards and a strong quality mindset.
- Lead cross-functional teams and influence peers and senior management; effectively lead both with and without formal authority.
- Engage with regulatory agencies/country authorities as an analytical subject-matter expert when required.
- Build external networks (vendors, consortia, academic/corporate partners) to stay ahead of evolving technical and regulatory expectations.
Qualifications
- Ph.D. in Chemistry, Analytical Chemistry, Chemical Engineering, Biochemistry, or a related scientific discipline; 12+ years with a graduate degree (either MS or PhD) or 14+ years with a BA/BS. Expertise in pharmaceutical/biopharmaceutical analytical development/product characterization.
- Demonstrated senior leadership experience leading highly technical organizations, with a track record of delivering through others.
- Deep expertise in phase-appropriate control strategy development and analytical method development and transfer to Quality organizations.
- Working knowledge of cGMP, data integrity expectations, and global regulatory requirements, with experience supporting successful US and international regulatory filings.
- Strong communication and presentation skills with the ability to distill complex technical content for diverse audiences.
- Small molecule analytical development across the lifecycle (discovery through commercial), including chromatography (HPLC/UPLC), mass spectrometry, impurity methods, stability, comparability, method validation, and test transfer.
- Proven ability to craft technical and innovation strategies and implement new methodologies to improve capability, robustness, and productivity.
- Demonstrated capability to solve complex quality, regulatory, and scientific problems under aggressive timelines.
