Senior Specialist, QC Analytical

Biopharma Careers; Leiden; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Bristol Myers Squibb in Leiden is seeking a Senior Specialist QC Analytical to perform method transfer/validation and routine testing across in-process, final product, and stability samples.

You will train new analysts, verify data, review GMP documentation, and support investigations and CAPA initiatives in a fast-paced, cross-functional QC team.

The role requires strong knowledge of LIMS, quality systems, and regulatory expectations, with 4+ years of relevant analytical experience.

Qualifications

• Bachelor’s degree or equivalent required, preferably in science. Advanced degree preferred.
• 4+ years of relevant analytical testing or QC experience in a regulated environment.
• Experience with cell and molecular biology techniques (HPLC/UPLC, flow cytometry, qPCR, ELISA) and aseptic technique.

Responsibilities

• Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Troubleshoot and solve problems with minimal guidance.
• Perform data verification, data review, and GMP documentation review for general and complex methods.
• Complete document revisions, CAPA and deviation/investigation tasks and continuous improvement.
• Train and mentor others on QC methods and GMP processes.
• Support other QC lab tasks as required.

Skills

Regulatory compliance

Technical writing

Cross-functional teamwork

Communication

Problem solving

Education

Bachelor's or higher in science

Master’s in bioanalytical science (NL)

Tools

LIMS

Document Management

Quality Management Systems

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.

Position summary:

The Senior Specialist QC Analytical is responsible for performing method transfer/validation and routine testing including troubleshooting and problem solving. The Senior Specialist is also responsible for performing data verification and review and training new analysts. Next to that, the Senior Specialist performs documentation review and other GMP or project related activities e.g., investigations.

Key Responsibilities:

• Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Anticipate and perform troubleshooting and problem solving with minimal guidance.
• Perform data verification, data review and review of GMP documentation for general and complex methods. Perform QC disposition of the SOTR.
• Perform document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• Train and mentor others on QC test methods, GMP processes and procedures.
• Perform other tasks as required to support the QC laboratories.

Qualifications:

Specific Knowledge, Skills, Abilities :

• Ability to accurately and completely understand, follow, interpret and apply BMS Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• Advanced knowledge of LIMS, Document Management and Quality Management and laboratory data analysis systems preferred.
• High problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.

Education/Experience/ Licenses/Certifications :

• Bachelor’s degree or equivalent required, preferably in science. Advanced degree preferred.
• NL: Master’s or Bachelor's degree /HLO in (bioanalytical) science required.
• 4+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Demonstrated experience in cell and molecular biology techniques (e.g. HPLC/UPLC assays, cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).

#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. If you require reasonable accommodations/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.

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/

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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.

R1605749 : Senior Specialist, QC Analytical