Associate Scientist, Analytical Strategy & Lifecycle

Bristol-Myers Squibb; Munster; Hybrid; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym

Life assurance

Job summary

Bristol-Myers Squibb in Ireland seeks an Associate Scientist, Analytical Strategy & Data Privacy to support late-stage and commercial programs, ensuring robust analytical method performance and regulatory compliance.

You will collaborate across analytical development, manufacturing, and quality, manage method validation activities, assist with regulatory filings, and contribute to continuous improvement of analytical strategies.

The role offers hybrid work, competitive salary, and benefits.

Qualifications

• Working knowledge of Analytical Strategy & Lifecycle and GMPs.
• Experience with a broad range of assays for testing biological products.
• Ability to collaborate with remote colleagues and communicate effectively.

Responsibilities

• Establish and maintain partnerships with stakeholders across analytical development, manufacturing, regulatory, quality and other departments.
• Support analytical activities for late-stage and commercial programs, ensuring robust method performance and regulatory compliance.
• Contribute to regulatory filings (BLAs, ROW, PAS) and respond to Follow-Up Measures and PMCs.

Skills

Cross-functional collaboration

Data analysis

Technical writing

Regulatory knowledge

Tools

HPLC

iCIEF

Gel electrophoresis

Capillary electrophoresis

Mass spectrometry

Spectrometry

ELISA

Job description

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

#LI-Hybrid

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number.

R1605850 : Associate Scientist, Analytical Strategy & Data Privacy Link

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.