Senior Specialist, QC Analytical

Bristol Myers Squibb; Leiden; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Hybrid work model

Comprehensive benefits

Job summary

Bristol Myers Squibb is seeking a Senior Specialist QC Analytical to perform method transfer/validation and routine testing of in-process, final product, and stability samples. You will troubleshoot issues, verify data, review GMP documentation, and contribute to investigations and continuous improvement.

The role requires 4+ years of analytical QC experience, a science degree, and strong knowledge of LIMS and GMP processes. Hybrid work options and comprehensive benefits are provided.

Qualifications

• Bachelor’s degree in science; advanced degree preferred.
• 4+ years of analytical testing or QC experience.
• Experience with HPLC/UPLC, cell/molecular biology techniques.

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 and review GMP documentation.
• Complete document revision, CAPA and deviation/investigation tasks.
• Train and mentor others on QC test methods and GMP processes.
• Perform other tasks to support the QC laboratories.

Skills

Regulatory knowledge

cGMP compliance

Data analysis systems

Technical writing

Communication skills

Team collaboration

Education

Bachelor’s degree in science

Advanced degree preferred

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.

• 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

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

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 workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin 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