Scientist, Analytical Sciences

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As a Scientist in Analytical Sciences and Projects, you will be part of a team responsible for the lifecycle management of the commercial specifications and analytical methods of the small molecule portfolio. You will also be responsible for QC lab method support & troubleshooting, method validations & transfers, lifecycle method monitoring & remediation; as well as analytical CMC strategy supporting product globalization. This work involves managing the analytical sections of the world-wide dossiers, authoring and reviewing regulatory filings, and responding to health authority inquiries.

Key Responsibilities:

• This position requires working independently and within project teams under the guidance of an experienced leader.  As the subject matter expert (SME) of the commercial methods you will be responsible for QC lab method support, method validations & transfers, troubleshooting, and lifecycle method monitoring. 

• Additional duties will be managing specifications, authoring and reviewing regulatory filings and responding to health authority inquiries.

• Create and maintain effective partnerships with stakeholders from Quality, Pharmaceutical Development, Internal QC laboratories, External QC and Manufacturing teams, Global Regulatory Sciences, Manufacturing Sciences and Technology, and Supply Chain to deliver analytical strategies with a high probability of technical and regulatory success. 

• Maintain and establish analytical strategies for product globalization and commercial lifecycle management of specifications and analytical methods.

• Manage change controls as needed for the implementation of analytical changes throughout the BMS network, third party manufacturing and outside testing labs. 

• Review documents and analytical sections of regulatory submissions and with support prepare/review responses to questions raised by Health Authorities.

• Collaborate with development teams during commercialization to become commercial method SME and ensure commercial method readiness. Provide analytical technical support during Launch activities.

• Provide technical expertise to QC testing sites (internal BMS and external) during method validations, transfers, routine testing and investigations. 

• Lead method transfers and validations, review data and assure methods are appropriately implemented at the QC labs supporting commercial manufacturing.

• Support global expansion of commercial programs by leading in-country method transfers and contributing to global submissions.

• Perform periodic method validation and performance reviews throughout the program’s lifecycle to ensure consistent and robust performance. Remediate methods as necessary if issues identified during routine analysis and periodic reviews. 

Key Requirements:

• BA/BS in science with at least 5 years; or MS in science with 3-5 years relevant pharmaceutical experience.  

• Demonstrated ability to perform independent work and works well within a team environment.

• Overall awareness of the pharmaceutical manufacturing and quality processes and regulatory requirements necessary for the manufacture and distribution of pharmaceutical products.

• Strong technology and scientific background in the application of analytical chemistry to pharmaceutical development, manufacture and control.

• Experience with chromatographic, spectroscopic, and other analytical techniques used to test and characterize small molecule drug substance and drug products. 

• Experience performing method validations and transfers, as well as troubleshoot method issues. 

• Knowledge of current regulatory principles, including cGMPs, as they apply to