Scientist, Analytical Strategy & Lifecycle

at  BristolMyers Squibb

WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED:

• 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

Education/Experience/ Licenses/Certifications:

• A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 2, 6 or 8 years of biologics experience within Analytical Strategy & Lifecycle / relevant field, respectively

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

THE ROLE

Bristol Myers Squibb is looking to recruit on a permanent contract Scientist, Analytical Strategy & Lifecycle to join our team in Dublin Ireland or Devens in the US.
A Scientist in the Analytical Strategy & Lifecycle bio group plays a supporting role for Biologic product lifecycle activities. This position focuses on providing support to commercial and late stage products with a specific focus on Analytical Strategy & Lifecycle strategy, enabling regulatory filings, provide technical partnership for quality control laboratories around the world, support managing the lifecycle of specifications (methods and acceptance criteria), and authoring responses to health authority questions on commercial products.
The scientist will operate in a matrix team responsible for technical SME support to QC, preparation of licensure applications, rest of world filings, follow-up measures, post-approval commitments and prior approval submissions. Through strong leadership and a level of independence, the scientist will ensure the support of analytical methods and analytical change control across the BMS network, for third party manufacturing and our partners at outside testing labs. The scientist is responsible for data gathering, interpretation and presentation to support decision making, and product analytical strategies.

KEY DUTIES & 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.
• Subject Matter Expertise: Can serve 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: 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.