Responsible for the oversight of outsourced analytical development activities associated with the development, validation, and technology transfer for chemical regulatory starting materials, intermediates and active pharmaceutical ingredients. Manages multiple contract service providers (CSPs) to deliver comprehensive, consistent, and compliant analytical development results in reports and certificates of analysis.
- 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 suitability of analytical methods for intended purpose
- Drafts and/or reviews method validation protocols and reports.
- Drafts and/or approves analytical methods.
- Provides information for chemistry, manufacturing and control (CMC) sections of regulatory documentation.
- Provides oversight of testing atcontractservice providers (CSPs):
- Reviews testing sections of process development protocols and reports.
- Defines testing requirements.
- Observes, as needed, testing at CSPs.
- Travels to sites to assess technical abilities and for formal planning activities
- Liaises with manufacturing, quality and regulatory counterparts to develop plans and protocols for API development.
- Conducts laboratoryinvestigations:
- Investigates and/or reviews CSP out-of-specification/out-of-trend (OOS/OOT) for scientific soundness and completeness.
- Assesses performance of CSP laboratory for accuracy and technical expertise
M.S. in Chemistry or related field. Ph.D. preferred. An equivalent combination of relevant education and applicable job experience may be considered. A minimum of 8 years’ experience in progressively responsible roles with a focus on API analytical development techniques with 5 years’ in a leadership role required.
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)
- Demonstrated problem solving abilities.
- Strong organizational and documentation skills.
- Demonstrated effective verbal and written communication skills.
- Ability to manage change in a dynamic environment.
- 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 creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.
- Ability to travel 20% of the time both domestically and internationally.