Specialist, QC Microbiology

Bristol-Myers Squibb; Cruiserath; On-site; EUR 35,000 - 55,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family medical allowance

27 days annual leave

Life assurance

On-site gym

Job summary

Bristol Myers Squibb Cruiserath Biologics is seeking a QC Microbiology Analyst to support the QC Microbiology Laboratory. You will perform sterility, endotoxin, bioburden, and growth promotion testing, with duties also spanning method transfer/validation and documentation to ensure cGMP compliance.

The role requires a Level 8 degree in Microbiology or related field and at least 1 year in a pharma laboratory, with strong communication and teamwork skills. A 12/7 shift pattern may be required.

Qualifications

• Minimum of a Level 8 degree in Microbiology or related discipline.
• At least 1 year of pharmaceutical/healthcare laboratory experience.
• Excellent written and verbal communication skills.
• Ability to work in a team-based collaborative environment.
• Sterility experience is desirable but not essential.

Responsibilities

• Perform Sterility testing on Drug Product samples.
• Perform Bacterial Endotoxin testing on Drug Product, Drug Substance, Raw Material and Utility samples.
• Perform Bioburden testing on Drug Substance, Raw Materials and Utility samples.
• Perform Growth Promotion testing of media lots entering the laboratory.
• Carry out identifications of Microorganisms isolated post testing activities.
• Carry out the Minute Mouse Virus by PCR for in-process samples.
• Perform compendial verification, method transfer/validation, and routine testing of in-process, drug substance and drug product samples.
• Complete all laboratory documentation in a timely and accurate manner.
• Ensure compliance with SOPs and registered specifications.
• Assist in authoring and reviewing documentation, including SOPs.
• Provide support to other departments to ensure qualification and production schedules are adhered to.
• Review Batch paperwork and reconciliation of analyses performed in the laboratory.
• Investigate alert/action limit excursions according to site procedures.
• Maintain high standard of housekeeping and safety in the laboratory.
• Perform any other activities as indicated by the Microbiology Manager.

Skills

Written and verbal communication

Team collaboration

Aseptic manufacturing awareness

Education

Level 8 degree in Microbiology or related discipline

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.

The Role

BMS Cruiserath Biologics is seeking to recruit a QC Microbiology Analyst within the QC Microbiology Laboratory . Reporting to the QC Microbiology Manger, the QC Microbiology Analyst will be responsible for supporting site activities related to Product Testing, performing testing of samples and laboratory duties in accordance with cGMP regulations.

Responsibilities will include (but not limited to):

• Performing Sterility testing on Drug Product samples.
• Performing Bacterial Endotoxin Testing on Drug Product, Drug Substance, Raw Material and Utility samples within required hold times.
• Performing Bioburden testing on Drug Substance, Raw Materials and Utility samples within required hold times.
• Performing Growth Promotion testing of media lots entering the laboratory.
• Carrying out identifications of Microorganisms isolated post testing activities.
• Carrying out the Minute Mouse Virus by PCR for in-process samples.
• Performing compendial verification, method transfer/validation, and routine testing of in-process, drug substance and drug product samples in accordance with applicable procedures and cGMP requirements.
• Completing all laboratory documentation in a timely and accurate manner.
• Compliance with Standard Operating Procedures and Registered Specifications.
• Assisting in authoring and reviewing documentation, including SOPs.
• Providing support to other departments to ensure qualification and production schedules are adhered to.
• Reviewing Batch paperwork, and reconciliation of analysis performed in the laboratory.
• Ensuring that any alert/action limit excursions are investigated according to site procedures.
• Ensuring a high standard of housekeeping and safety is maintained in the laboratory.
• Performing any other activities as indicated by the Microbiology Manager.

Qualifications and Experience required:

• The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or related discipline.
• At least 1 years' experience in a pharmaceutical / healthcare laboratory or related technical function.
• A strong background in Microbiology and aseptic manufacturing is desirable but not essential.
• The successful candidate must demonstrate excellent written and verbal communication skills.
• The ability to work in a team based collaborative environment is essential.
• Sterility experience is desirable but not essential.

Note: This candidate may be required to work a 12/7 shift pattern.

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 an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym.

#LI-Onsite

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/

For roles based in Washington State only:

If you live in or expect to work from