Associate Scientist, Analytical Strategy & Lifecycle

Key Responsibilities:

• Cross-Functional Collaboration: Establish and maintain effective partnerships with stakeholders across analytical development, manufacturing, supply chain, regulatory, quality, and other relevant departments to deliver high-quality analytical strategies.
• Can support ASL Analytical Product Leads working together as a QC technical point of contact for project activities, supporting evaluations of methods and data to support project goals.
• Method Lifecycle Management: Support analytical activities for late-stage and commercial programs, ensuring robust method performance and compliance with regulatory standards.
• Regulatory Support: Contribute to regulatory filings (BLAs, ROW, PAS) and respond effectively to Follow-Up Measures (FUMs) and Post-Marketing Commitments (PMCs).
• Method Troubleshooting and Optimization: working together with the APL to provide technical support to QC teams for method troubleshooting, tech transfers, validations, and investigations. Periodically review method performance and lead remediation efforts as needed.
• Change Control and Strategy Implementation: With guidance from superior, support in the implementation of control strategies, analytical method changes, and specification adjustments across the BMS network, third-party manufacturers, and external testing laboratories.
• Contribute to improvement projects of low to moderate complexity, aimed at enhancing efficiency, compliance, and method robustness
• Serve as a technical liaison, facilitating effective communication and collaboration between QC and other departments, enhancing cross-functional understanding and operational synergy.

Qualifications & Experience
 

• Requires working knowledge of the relevant principles and concepts of Analytical Strategy & Lifecycle (JOS / Analytical Procedures / Method Validation etc.) and associated GMP’s.
• Understanding and industry hands-on experience with a broad range of assays for testing and characterizing biological products, such as HPLC, iCIEF, gel and capillary electrophoresis, and various spectrometry techniques (e.g., MS, absorption), along with ELISAs.
• An understanding of method qualification and validation, underpinned by an understanding of regulatory guidelines and a commitment to cGMP laboratory operations, ensuring compliance across all activities.
• Demonstrated ability to collaborate effectively with remote colleagues and within a matrix organizational structure, supported by excellent written and verbal communication skills.
• Demonstrated capability to analyze complex data and draw actionable conclusions, coupled with proficiency in authoring formal reports, technical documents, and scientific communications, highlighting strong analytical and writing skills.
• Ability to work independently on a majority of Analytical Strategy & Lifecycle tasks, showing a degree of initiative and responsibility in a regulatory-compliant manner

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days of annual leave , access to BMS Cruiserath on-site gym and life assurance 

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