Sr Scientist II – Analytical Development Small Molecule

Sr Scientist II – Analytical Development Small Molecule

Requirements

• Ph.D. in Analytical Chemistry or a related field and a minimum of 2 years of related experience; or, Equivalent combination of education and experience.
• Hands-on experience and solid understanding of high-resolution technologies, such as QTof, QQQ, and Orbitrap, and their use in structural elucidation of impurities.
• Hands-on experience in analytical development in the pharmaceutical industry.
• Experience in developing and validating analytical methods, specifically reversed phase HPLC/UPLC methods, chiral methods, GC methods, and LCMS methods, for testing small molecule drug substances and drug products.
• Experience of conducting stability programs.
• In-depth knowledge of Good Manufacturing Practices (GMP) and FDA/ICH and EU regulations and guidelines.
• Experience in regulatory filings, such as IND, IMPD and NDA.
• Ability to communicate clearly and effectively, both verbally and in writing.
• Detail oriented, data-driven, and self-motivated.

Responsibilities

• Work closely with DS or DP Lead and provide analytical support to process development and manufacturing: timely method development and validation, impurities analysis and mapping, and phase-appropriate specification and control strategies.
• Design, plan and execute experiments to support project goals including, but not limited, method development, method understanding, investigation and troubleshooting.
• Manage analytical development activities both internally and at contract laboratories with best practices in support of Exelixis pharmaceutical development from discovery to NDA.
• Contribute effectively towards strategic and tactical development of project plans with emphasis on analytical aspects and phase appropriate development.
• Provide expertise of various analytical techniques to help CMC development: HPLC/UPLC (reversed phase and chiral), GC, LCMS, FTIR, NMR, KF, XRPD, PSD, TGA, DSC, Peptide Mapping, etc.
• Provide strategic and tactical inputs toward assessing and identifying any at risk or potential problematic areas within analytical testing activities at CDMOs and provide effective solutions to mitigate before these areas result in any issues.
• Perform hands-on documentation and data review and provides significant contributions and oversight to contract labs for protocols, deviations, investigations, CAPA’s, reports, stability data, trending, specification setting, shelf-life/retest dating, using, where applicable, current regression analysis practices and other relevant statistical techniques.
• Work closely with contract labs to directly oversee transfer of methods, validation, and QC testing to ensure they are executed successfully and with best practices.
• Author, prepare and review relevant sections of CMC submissions in support of regulatory filings.
• Collaborate effectively within CMC and with QA and RA and outside contract laboratories with excellent communication to maintain strong relationships.
• Stay current with changing regulatory requirements regarding analytical testing.
• Help to identify and draft work instructions/SOP for relevant analytical functions.
• Train junior scientists.

Preferred Qualifications

• Experience in drug-linker technology and chemistry is a plus.
• Experience of working with contract laboratories is also highly desirable.
• Hands-on experience and in-depth knowledge with instrumentation software such as Empower, MassLynx, ChemStation, JMP, etc.
• Experience in managing small groups of scientists.