Director, Analytical Development

Major Responsibilities:
- Provide leadership, strategic guidance, and talent development for analytical and pharmaceutical scientists supporting global development and commercial support.
- Define and communicate industry-leading analytical strategies for NCEs, peptides, and other new modalities.
- Develop, validate, and transfer analytical methods aligned with strategies.
- Establish analytical capabilities to support process development, formulation, technology transfer, and post-approval changes.
- Drive fundamental understanding of drug release and product performance; develop biopharmaceutics risk assessment and biowaiver strategies.
- Solve complex technical issues in an evolving regulatory landscape.
- Balance resources, resolve issues, and achieve target timing for pipeline projects and strategic initiatives.
- Drive technical excellence and scientific innovations to improve organizational capability and productivity.
- Collaborate across R&D and Operations to align development strategies.
- Partner in commercial initiatives for modernization of manufacturing and controls.
- Manage and develop scientific talent (20–30 scientists, senior scientists, and managers) across multiple disciplines/projects.
- Ensure scientific excellence and foster professional development.
- Lead analytical development interactions with regulatory agencies and deliver regulatory filing packages.
- Identify, evaluate, and propose internal/external collaborations to drive scientific innovation.
- Ensure compliance with Environmental Health and Safety regulations for the group.

Qualifications:
- PhD with at least 10 years of relevant pharma/biotech industry experience, or Master’s with at least 15 years.
- Proven experience leading a CMC development organization across experience levels and scientific disciplines.
- Skills in physical characterization, structural elucidation, and relating compound/formulation properties to performance.
- In-depth knowledge of relevant regulations; NDA and/or BLA experience.
- Extensive understanding of analytical control strategies, dissolution, biopharmaceutics, formulation development, regulatory filings, manufacturing, QA, and supply chain.
- Demonstrated success leading strategic initiatives and new technology evaluation/implementation.
- Track record in people management and leading matrix teams.
- Strong oral and written communication skills.
- Experience maintaining morale in compliance-required environments.
- Strong negotiating, influencing, and leadership skills.