Principal Scientist, Analytical Development

The Opportunity:

• Serve as a key analytical development SME, providing strategic leadership on phase appropriate control strategies for API and drug product, including specification setting, analytical method development, and lifecycle management.
• Lead and drive day to day analytical activities supporting the development, characterization, and manufacturing of API and drug product, while actively contributing to cross functional PDM project teams.
• Author and review Quality sections of regulatory submissions, and effectively address queries from regulatory agencies.
• Evaluate, select, and implement appropriate analytical technologies and strategies, while managing external partners including CDMOs and contract testing laboratories for analytical method development, validation, transfer, release testing, and investigation/resolution of OOS/OOT events.
• Prepare, review, and approve technical protocols, reports, specifications, and supporting documentation to ensure scientific rigor and regulatory compliance.
• Partner closely with cross functional teams including Drug Product, Drug Substance, Regulatory Affairs, QA, Project Management, Medicinal Chemistry, DMPK, and Toxicology to advance project milestones and enable timely achievement of development goals.

Required Skills, Experience and Education:

• PhD (minimum MS) in Analytical Chemistry, Organic Chemistry, or a related scientific discipline.
• 10+ years of experience in analytical development within the pharmaceutical or biotechnology sector.
• Demonstrated success leading cross functional projects with strong organizational and execution skills.
• Extensive hands on and strategic leadership experience supporting analytical activities across small molecule drug development, preferably with depth in late-phase development and commercialization readiness.
• Excellent communication and influencing skills, including verbal, written, and presentation abilities, coupled with strong collaboration, planning, and people leadership capabilities.
• Deep scientific and technical understanding of CMC strategies and analytical enablement for small molecule development programs.
• Proven experience managing external partners, including CROs and CDMOs, to ensure high quality deliverables and program execution.
• Working knowledge of global regulatory requirements and experience supporting regulatory submissions, including INDs, IMPDs, NDAs, and/or MAAs.
• Comprehensive understanding of ICH guidelines, GMP regulations, and current industry best practices related to analytical development and quality.
• Strong critical thinking and innovation mindset with the ability to independently evaluate complex issues, identify risks, and implement effective solutions.
• Excellent technical problem-solving skills with sound scientific judgment and data driven decision-making capabilities.
• Ability to effectively prioritize multiple responsibilities and thrive in a dynamic, fast paced, and highly collaborative environment.

Preferred Skills:

• PhD in Analytical Chemistry, Organic Chemistry, or a related scientific discipline.
• Project leadership and CDMO oversite experience.
• Late phase development and regulatory submission.

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