Senior Specialist, QC Analytical, Cell Therapy

Bristol Myers Squibb; Leiden; On-site; EUR 60,000 - 85,000; Full time

Job summary

Bristol Myers Squibb in Leiden is seeking a Senior Specialist, QC Analytical, Cell Therapy to support QC testing across in-process, final product, and stability samples. You will perform method transfer/validation, data review, and contribute to deviations, CAPA, and continuous improvement.

The role requires training and mentoring others on QC methods (Flow cytometry, qPCR, ELISA, HPLC/UPLC) and adherence to Global Regulatory and cGMP requirements. Two weekends per month work is required.

Qualifications

• Bachelor's degree in science or equivalent.
• 4+ years of QC experience in a regulated environment.
• Experience in cell and molecular biology techniques.

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 document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• Train and mentor others on QC test methods (Flow cytometry, PCR, Cell based assays and HPLC/UPLC), processes and procedures.
• Perform other tasks as assigned.

Skills

QC Testing

GMP Docs

Troubleshooting

Data Review

Flow Cytometry

qPCR

ELISA

HPLC/UPLC

Cell-based Assays

Training Mentoring

Education

Bachelor's degree in science

Bioanalytical science degree

Tools

LIMS

ELN

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

Responsible for supporting QC testing for in-process, final product, and stability samples, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts.

Please note that this role requires to work two weekends a month.

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 document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• Train and mentor others on QC test methods (Flow cytometry, PCR, Cell based assays and HPLC/UPLC), processes and procedures.
• Perform other tasks as assigned.

Qualifications

Specific Knowledge, Skills, Abilities

• Ability to understand, follow, interpret, and accurately and completely apply Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• 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.
• Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.

Education/Experience/ Licenses/Certifications

• Bachelor's degree or equivalent required, preferably in science. Netherlands 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., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).

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/

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.

R1605750 Senior Specialist, QC Analytical, Cell Therapy