Senior Scientist, Analytical Development (Small Molecule)

About the role

The Senior Scientist, Analytical Development, is responsible for analytical development activities for small molecule drug substances from preclinical through commercial phase. This role is laboratory-focused, requiring deep expertise in analytical chemistry and strong problem-solving skills.

Responsibilities

• Perform development and optimization of phase-appropriate analytical methods for starting materials, intermediates, and drug substances to support programs from early development through commercialization using techniques such as HPLC, GC, MS, IC, FTIR, UV, NMR, KF and other relevant techniques to ensure method suitability for intended purpose
• Perform analytical method verification and validation within cGMP compliance and in accordance with regulatory guidelines
• Perform analytical development activities for the characterization of small molecules utilizing various chemical-physical characterization techniques
• Conduct stability studies, forced degradation studies and support impurity identification
• Independently lead and execute analytical development activities and contribute to overall control strategy for assigned projects
• Provide scientific leadership and technical support for quality investigations, including OOS/OOT events, deviations, root cause analyses, and CAPAs
• Maintain accurate and comprehensive laboratory documentation in compliance with company procedure
• Represent Analytical development on cross-functional teams. Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects
• Support CMC regulatory documentation and filings as needed
• Support off-site analytical transfers, manufacturing support, and interaction with contractors
• Clearly communicate analytical results, risks, and recommendations through high-quality technical reports, presentations, and cross functional discussions across the company
• Create and implement novel concepts and techniques to support analytical activities with Chemical and Product Development
• Contribute to development of policies and department strategies
• Partner closely with other team members to develop and implement best practices
• Build and enhance internal and external professional relationships
• Support career development and technical growth of team members

Requirements

• BS/BA in Chemistry/Biochemistry or related discipline and 5+ years of experience in the analytical/pharmaceutical development field.
• Hands-on experience in method development, validation, transfer and execution in Analytical Chemistry OR
• MS/MA in Chemistry or related discipline and 3+ years of experience OR
• PhD in Analytical Chemistry or related discipline and some relevant experience; may include postdoc experience
• Strong technical expertise in testing, method development, verification, validation, characterization and support of stability studies for small molecule programs
• Technical proficiency with techniques that include, but are not limited to, HPLC, UPLC, GC, KF, IC, IR, MS, Spectroscopy, UV, and XRPD
• Experience and understanding of analytical chemistry, pharmaceutical development, and phase appropriate control strategies
• Excellent interpersonal skills with strong oral and written communication abilities, including drafting and reviewing technical documents
• Excellent laboratory and productivity skills
• Comprehensive understanding of cGMP requirements in drug substance and drug product
• Expert knowledge of cross-functional understanding related to drug development
• Knowledge of FDA, EMA, WHO, and ICH regulatory requirements