Sr. Scientific Director, Analytical Development

Role Summary

Sr. Scientific Director, Analytical Development at Neurocrine Biosciences. Recognized as an internal and external strategic scientific expert and leader in advanced analytical technologies for CMC development. Leads analytical method development, validation/qualification/transfer, stability studies, specification setting, and regulatory submissions to support clinical manufacturing and development from preclinical to commercialization.

Responsibilities

• Responsible for scientific and strategic direction of CMC analytical development including method development and validation, specification setting, physicochemical characterization, stability and control strategies for preclinical and clinical drug candidates, focusing on biomolecules
• Develops and implements analytical methods for drug substances and drug products including Liquid Chromatography, Mass Spectrometry, Proteomics, Capillary Electrophoresis, and Bioassay to support preclinical through commercial activities
• Develops control strategies and methodologies for process and product related impurities and degradation products
• Leads CMC/analytical projects and project teams and represents CMC and Analytical Development on cross-functional teams
• Establishes and leads external relationships with CROs/CMOs to drive analytical method and technology transfer
• Oversees and contributes to Chemistry, Manufacturing and Controls (CMC) sections in regulatory dossiers
• Provides effective supervision of junior technical leaders, laboratory personnel and guidance for their career development
• Recommends solutions to technical problems as it relates to CMC control strategy and critical quality attributes and has broad impact on multiple functional areas
• Other duties as assigned

Qualifications

• BS/BA degree in Analytical Chemistry, Biochemistry, Chemistry and/or related science discipline and 15+ years of experience OR
• Masters in Chemistry, Pharmacy and/or related science discipline and 13+ years experience OR
• PhD in Chemistry, Pharmacy and/or related science discipline and 10+ years of similar experience noted above
• Ability to lead analytical and project teams and being independent on daily interactions with internal cross-functional teams and external analytical CMO/CROs
• Expert in developing advanced analytical methods for biological products, including U/HPLC, CE-SDS, iCIEF, SEC, MS, ddPCR, qPCR, ELISA, bioassay, etc.
• Proficient in ICH and health authority guidance for analytical method validation, stability, control strategies, CTD, and submission of analytical data
• Ability in developing specifications, stability and control strategies
• In-depth understanding of cGMPs, including CMC regulatory information required for CTA/IND/NDA/BLA with respect to chemical and bioprocess, formulation, analytical methods, and control strategy
• Understanding of parenteral and combination product development, including compatibility and in-use stability of these products
• Experience in analytical characterization, chemical process and formulation development of small molecules is preferred
• Recognized as an internal thought leader with extensive technical and strategic expertise in analytical development and physicochemical characterization of peptides, biomolecules, and related materials including cell banks, starting materials, drug substances, and drug products
• Applies in-depth knowledge of advanced analytical technologies in separation science, mass spectrometry, spectroscopy, bioassay, and other scientific expertise to solve critical issues
• Ability to effectively interact with internal partners such as QA, Regulatory CMC, and Preclinical as well as with CDMOs
• Proven ability to translate strategy into tactical plans and drive outcomes
• Strong leadership, coaching, and employee development skills, including mentoring teams and different levels of scientists
• Ability to work in a cross functional team and matrix environment
• Excellent written, presentation, and verbal communication skills

Education

• As listed in Qualifications

Additional Requirements

• None beyond the above qualifications