The Senior Manager/Associate Director of Chemistry and Manufacturing and Controls (CMC) will join the Analytical Development Team and report to the Director of Analytical Development. This role will work closely with the entire CMC team to execute late-stage development activities in support of Phase III clinical trials as well as NDA readiness activities. Candidates for this position will be required to work independently and have experience managing outsourced analytical activities at contract manufacturing sites and testing labs.
• Oversee 3rd party development of analytical methods, method validation, and investigations for out of specification, out of trend, and/or anomalous results.
• Collaboratively plan and execute cross functional studies for chemical development and formulation development.
• Manage GMP stability studies and provide trend analysis in support of retest and shelf-life extension.
• Manage reference standard program (qualification, storage, inventory, distribution)
• Development and approval of specifications for raw materials, intermediates, and finished product and knowledge of regulatory requirements in setting of specifications.
• Development and validation of analytical methods and verification of compendial methods.
• Able to communicate results both internally and externally through oral and written updates and formal reports as necessary.
• Provide analytical support for API and Drug Product process development.
• Authoring of development reports, protocols, and methods.
• Support quality audits as a technical representative and contribute to authoring of audit reports.
• Ph. D./M.S. in chemistry/biochemistry preferred. B.S. in chemistry/biochemistry will also be considered with an additional 5 years of relevant industrial experience.
• At least 7 years of experience in analytical development in a pharmaceutical setting.
• Proven leadership experience in managing analytical chemists at various levels externally (CMO mgmt.).
• Independently proficient in a variety of analytical techniques and regulatory areas including, but not limited to: HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, and phase appropriate analytical method validation.
• Knowledge and direct experience with CMC analytical regulatory requirements and authoring of IND/IMPD filings and response to regulatory inquiries. Experience applying regulatory guidelines (ICH, FDA, EMA etc) to pharmaceutical development and CMC strategy
• Ability to communicate effectively with vendors regarding project scope, scientific results and project updates. Ability to understand project timelines and appropriately prioritize activities to achieve project goals.
• The position will require an ability to adapt to changes in priorities on short notice and will also require an ability to make decisions, independently, under tight timelines.
• Position requires 20% travel. Must have the ability to travel internationally.
Highly Desirable Skills:
• 2+ years of experience with hands-on cGMP analytical testing
• Experience with statistical analysis software
• Experience with chromatography data systems and laboratory information management systems
• NDA/MAA authoring experience
• Disintegration, DSC, TGA, hardness, and friability testing