Responsible for supervising outsourced analytical development activities associated with the development, validation, and technology transfer for chemical regulatory starting materials, intermediates and active pharmaceutical ingredients. Support characterization of Regulatory Starting Material (RSM), intermediates, and drug substances. Manages multiple contract service providers (CSPs) to deliver comprehensive, consistent, and compliant analytical development results in reports and certificates of analysis.

Primary Responsibilities

• Develops and validates analytical methods for small molecules for raw materials, intermediates and active pharmaceutical ingredients (API):
• Direct the analytical development plans and testing requirements at CSPs
• Collaborates with testing labs to develop analytical methods
• Assess the suitability of analytical methods for the intended purpose
• Drafts and/or reviews/approves method validation protocols and reports
• Drafts and/or reviews/approves analytical methods
• Draft analytical portions of the chemistry, manufacturing, and control (CMC) sections of regulatory documentation
• Provides oversight of testing at CSPs:
• Review testing sections of process development protocols and reports
• Defines testing requirements
• Observe, as needed, testing at CSPs
• Travels to sites to assess technical abilities and for formal planning activities
• Liaises with chemistry, manufacturing, quality, and regulatory counterparts to develop plans and protocols for API development
• Conducts laboratory investigations:
• Investigate and/or review CSP out-of-specification/out-of-trend (OOS/OOT) for scientific soundness and completeness
• Assesses the performance of CSP laboratory for accuracy and technical expertise

Education and Experience

• M.S. in Chemistry or related field. Ph.D. preferred
• Targeting 8 years' experience in progressively responsible roles, with a focus on API analytical development techniques, with 5 years in a leadership role
• Experience authoring technical reports and CMC sections for regulatory filings. Related experience should include hands-on experience in at least one of the following: analytical chemistry techniques: chromatography, thermo analysis and/or spectroscopic techniques
• Experience with oversight management of CSP analytical laboratory preferred
• Strong understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH guidances, 21 CFR Part 211, 21 CFR Part 11)
• Working knowledge of United States Pharmacopeia (USP), European Pharmacopeia (EP)
• Proven problem-solving abilities
• Strong organizational and documentation skills
• Demonstrated effective verbal and written communication skills
• Ability to manage change in a dynamic environment
• Strong understanding of analytical methods required for testing small molecules and peptides throughout their synthetic steps
• Skilled at negotiating with business partners or management and influencing senior-level leaders regarding matters of significance to the department or segments of the organization
• Adept at crafting and communicating a clear vision among team members optimally aligning resources to achieve functional area goals
• Ability to travel 20% of the time, both domestically and internationally

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds. Ability to travel by car or airplane independently up to 20% of the time and work after hours if required by travel schedule or business needs.

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