Sr. Scientist, Analytical Chemistry, CMC

Role Summary

Sr. Scientist, Analytical Development to support small-molecule pharmaceutical development Chemical Development within the CMC team. Lead analytical projects with minimal supervision and perform laboratory experiments to support both early- and late-stage programs.

Responsibilities

• Develop and execute analytical methods using a range of techniques including HPLC/UPLC, HRMS, GC, HS-GC, MS, IC, NMR, TGA, DSC, PXRD, PSD, KF, and FTIR for drug substances, intermediates, raw materials, and developmental compounds
• Lead analytical method development, validation, and troubleshooting under minimal supervision
• Conduct and document investigations related to OOS, OOT, or anomalous results
• Author analytical sections of regulatory submissions (e.g., NDA, IND, IMPD, CTA) in alignment with global regulatory guidelines and internal quality standards
• Perform in-silico assessments for potential mutagenicity and Nitrosamine CPCA risk, following current regulatory guidance
• Provide technical leadership and mentorship to junior scientists to foster scientific growth and ensure high-quality output
• Collaborate cross-functionally with chemical and formulation development teams to design and execute analytical studies
• Ensure compliance with SOPs, data integrity policies, and regulatory requirements through meticulous documentation and recordkeeping
• Review and approve internally generated and externally sourced analytical data
• Plan and execute in-house stability studies for APIs, intermediates, and prototype drug products
• Coordinate instrument maintenance and service; perform routine upkeep as trained
• Support laboratory operations, including inventory control and glassware management
• Actively contribute to a culture of continuous improvement, scientific excellence, and operational efficiency
• Perform other duties as assigned

Qualifications

• BS/BA in Analytical Chemistry or related field with 10+ years of relevant pharmaceutical R&D or QC experience
• MS/MA in Analytical Chemistry with 8+ years of relevant industry experience
• Ph.D. in Analytical Chemistry with 5+ years of relevant industry experience
• Strong hands-on experience with HPLC and related troubleshooting
• Practical knowledge of MS, GC, and other analytical instrumentation
• Understanding of cGMP standards and regulatory requirements for analytical method development and documentation
• Proficiency in data acquisition and analysis software, as well as Microsoft Office applications
• Demonstrated ability to analyze and interpret complex data sets and draw scientifically sound conclusions
• Solid foundation in analytical chemistry principles and laboratory practices
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities
• Strong written and verbal communication skills, with the ability to work independently and in collaborative teams
• Experience authoring and contributing to regulatory filings such as INDs, NDAs, IMPDs, and CTAs
• Familiarity working with international CMOs and external testing labs
• Project management experience and a proactive, problem-solving mindset

Skills

• Analytical technique proficiency: HPLC/UPLC, HRMS, GC, HS-GC, MS, IC, NMR, TGA, DSC, PXRD, PSD, KF, FTIR
• Analytical method development, validation, and troubleshooting
• Investigations of OOS/OOT and anomalous results
• Regulatory submission preparation (NDA, IND, IMPD, CTA)
• In-silico mutagenicity and Nitrosamine risk assessment
• Technical leadership and mentorship
• Cross-functional collaboration with chemical and formulation development teams
• Documentation, data integrity, and regulatory compliance
• Regulatory filings experience and CMOs/external labs collaboration
• Project management and process improvement mindset

Education

• BS/BA in Analytical Chemistry or a related field
• MS/MA in Analytical Chemistry (preferred)
• Ph.D. in Analytical Chemistry (advanced)