Senior Principal Scientist. Analytical Science

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Position Summary

The Senior Principal Scientist in Analytical Science will be in the department of Global Quality Control Operations and Analytical Sciences. The incumbent will be responsible for leading multiple analytical aspects of a small molecule product throughout its commercial lifecycle.  They will participate on cross-functional teams as the analytical representative on technical and CMC topics.  The person is expected to have significant knowledge of small molecule API and drug product methods and experience working on commercial regulatory dossiers, health authority responses, as well as analytical CMC strategy.   A strong understanding of GMP is required.

Key Responsibilities:

Own the analytical lifecycle management of the BMS commercial small molecule products.

• Provide analytical subject matter expertise and overall lifecycle management of commercial release methods and specifications

• Participate on cross-functional teams as the analytical SME

• Support the commercial stability and reference standards groups

• May lead a matrixed team of commercial analytical scientists

• Collaborate with development teams to ensure analytical commercial readiness of late-phase projects (methods and specifications for the analytical overall control strategy)

• Implement methods for small molecule API, drug products, process intermediates, and regulatory starting materials at commercial QC testing sites.

• Lead method validations and validation gap assessments to ensure validations are up to current standards, perform method validation remediation, as necessary

• Lead method transfer to BMS or external QC laboratories for the purpose of globalization and lifecycle management (including bringing on new manufacturing sites)

• Write formal analytical documents such as validation protocols/reports, method transfer protocols/reports and investigations reports

• Provide expertise and guidance for problem-solving including method troubleshooting, laboratory investigations, deviations, and CAPA’s,

• Collaborate with MS&T on continuous improvement initiatives

• Evaluate and participate in the review and implementation of compendia changes with impact to analytical methods

• Develop and execute on the analytical CMC strategy to globalize small molecule products

• Prepare and review technical documents

• Prepare and review analytical CMC sections of commercial regulatory submissions and address analytical-related inquiries from health authorities.

Qualifications & Experience:

• Bachelor’s degree in Chemistry or a related field with at least 12 years of experience or Master’s degree in Chemistry or a related field with at least 10 years of experience or PhD in Chemistry or a related field with at least years 8 of experience

• Strong technology and scientific background in the application of analytical chemistry to small molecule CMC

• Advanced knowledge and understanding of cGMPs

• Experience working in or with QC laboratories

• Knowledge of analytical method development validation and transfer requirements

• Experience with regulatory / analytical CMC requirements

• Demonstrated ability to be SME for analytical trouble-shooting and problem-solving

• Experience in the authoring and reviewing technical documents, analytical sections of commercial regulatory files and responding to analytical health authority inquiries

• Overall awareness of the pharmaceutical manufacturing &