Associate Scientist, Analytical Strategy & Lifecycle

Biopharma Careers; Munster; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym

Job summary

Bristol Myers Squibb招聘 Associate Scientist, Analytical Strategy & Lifecycle, to work collaboratively across analytical development, manufacturing, regulatory, and quality teams. You will support method lifecycle management, regulatory filings, and technical troubleshooting within a global network.

The role emphasizes independent work on analytical strategy tasks, quality/compliance, and strong scientific communication.

Qualifications

• Working knowledge of Analytical Strategy & Lifecycle (JOS / Analytical Procedures / Method Validation) and GMPs.
• Understanding of assays for biological products (HPLC, iCIEF, gel/capillary electrophoresis, MS, ELISAs).
• Knowledge of qualification/validation; regulatory guidelines and cGMP operations; strong writing skills.

Responsibilities

• Establish and maintain partnerships with stakeholders across analytical development, manufacturing, regulatory, quality, and other departments to deliver analytical strategies.
• Serve as QC technical point of contact for project activities, supporting method evaluations and data to support project goals.
• 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 Post-Marketing Commitments.
• Assist with method troubleshooting, tech transfers, validations, investigations; review method performance and lead remediation efforts.
• Support in change control and strategy implementation across BMS network and external labs.
• Contribute to improvement projects to enhance efficiency, compliance, and method robustness.
• Act as technical liaison between QC and other departments to improve cross-functional collaboration.

Skills

Cross-functional collaboration

Analytical thinking

Regulatory awareness

Scientific communication

Education

Bachelor's degree in life sciences

Tools

HPLC

iCIEF

Gel electrophoresis

Capillary electrophoresis

MS

ELISAs

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”, a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

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 willbe part ofa 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

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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodations/adjustmentsprior to accepting a job offer. If you require reasonableaccommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1605850 : Associate Scientist, Analytical Strategy & Lifecycle