Principal Scientist, Analytical Development

Role Summary

Playing a critical role as the analytical development technical lead, the position will be responsible for analytical development activities leading to NDA submission and commercialization, as well as development and execution of the CMC strategy. The individual will provide technical and project leadership, and work with cross-functional stakeholders to ensure analytical development and CMC activities are executed seamlessly and in alignment with the integrated CMC development plan and program timelines.

Responsibilities

• Lead the development and implementation of analytical strategies to advance new chemical entities (NCE) from preclinical lead optimization stage through commercialization.
• Drive analytical method development, optimization, validation, and troubleshooting, and characterization activities for both drug substances (DS) and drug products (DP).
• Develop and oversee quality control strategies, including quality risk management, specifications development, analytical package for DS and DP registration, validation, and commercial readiness.
• Author and review technical documents, analytical sections of regulatory documents (INDs, IMPDs, NDAs, MAAs, J-NDA, etc.), and responses to regulatory agencies.
• Stay current with emerging analytical technologies and regulatory trends, drive innovation and continuous improvement across analytical workflows.
• Build, mentor, and lead a high-performing analytical development team, foster a culture of scientific excellence, collaboration, and accountability both internally and with external partners.
• Collaborate cross-functionally with teams in drug substance, drug product, supply chain, quality, regulatory, clinical pharmacology, and toxicology to ensure alignment and execution of CMC and program objectives.

Qualifications

• Required: PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 12+ years of industry experience; or MS with 15+ years.
• Required: Deep expertise in small molecule analytical method development and characterization in the pharmaceutical/biotech industry.
• Required: Proven track record of leading analytical development through all phases of drug development, including NDA/MAA submissions.
• Required: Strong knowledge of GMP regulations, quality systems, ICH guidelines, and regulatory expectations (FDA, EMA, etc.).
• Required: Extensive experience managing CROs and working in a virtual development model.
• Required: Strong problem-solving skills with strategic and technically sound decision-making ability.
• Required: Excellent written and verbal communication skills and interpersonal skills.
• Required: Energetic, team-oriented, and adaptable to a fast-paced, dynamic environment.
• Preferred: Experience with small molecule oncology drug development.