Job Description

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us

Education and Experience:

Bachelor’s Degree or Associate’s Degree in Pharmacy, Microbiology Science or biotechnology or equivalent experience

4+ years Quality Control and/or Quality Assurance experience in a pharmaceutical company or other related industry with cGMP requirements.

An equivalent combination of education/experience may substitute.

Qualifications & Experience

Required Competencies: Knowledge, Skills and Abilities

Advanced knowledge of microbiological testing and techniques (Plate counts, Dilutions, Gram Stain technique, Biological Indicator, Bioburden, Endotoxin and Sterility) equipment/systems, scientific and technical principles.

Advanced knowledge of cGMPs, USP, Pharm. Eur., JP, ISO, FDA Regulatory Requirements, and scientific principles related to microbiological testing and environmental monitoring.

Advanced proficiency in MS Office Suite applications (Word, Excel, PowerPoint, Outlook, Teams).

Advanced ability to interpret/ write complex business and technical documents.

Advanced critical thinking, decision making and problem-solving skills.

Advanced written and verbal communication skills.

Advanced organizational skills.

Advanced GMP documentation skills.

Advanced time management, organizational and multi-tasking skills.

Advanced knowledge on how to conduct effective training and mentoring of peers.

Advanced knowledge of laboratory safety practices

Intermediate knowledge of how to make and deliver formal presentations to internal and external audiences.

Intermediate project management skills; capable of leading teams; cooperative and works well with a team.

Strong attention to detail.

Strong team and individual leadership skills.

Ability to work independently for extended periods of time.

Ability to communicate effectively with peers, management, and cross-functionally across the site.

Ability to train to and perform environmental monitoring sampling, testing and media fill reads.

Comprehensive understanding of validation concepts and principles.

Willingness to learn and share knowledge.

Continuous improvement mindset.

Key Responsibilities:

Provides technical and microbiological sampling and testing support to QC Microbiology.

Microbiology testing including, but not limited to, Bioburden, Bacterial Endotoxin (BET), Sterility, Biological Indicators, Identifications, Environmental Monitoring, Growth Promotion, incoming media/reagent Quality Control and Media Fill reads.

Cross functional testing duties such as Gram staining, Identifications, Bioburden, Bacterial Endotoxin Testing (BET), Sterility, Growth Promotion, incoming media/reagent Quality Control, Biological and Endotoxin Indicator Testing, as needed.

Support the development, writing, and reviewing for isolator and room validation Environmental Monitoring Performance Qualification (EMPQ) protocol and execution. Support routine test program, and training of analyst as needed. 

Support of the aseptic manufacturing contamination control program: personnel and material flow into the controlled areas, isolator and glove technology, cleaning and disinfection, utility qualifications, MODA program and media fills.

Support microbiology process, equipment and procedure implementation.

Support method transfer across site-to-site operations and execute method transfer protocols.

Support Microbiology alignment between internal manufacturing sites and Microbiology COE Directives.

Draft, review, revise and implement technical documents, including Protocols, Summary Reports, SOPs, Work Practices, Forms, Test Plans, Risk Assessments and Deviations.

Support and own quality actions such as (Deviations, CAPAs, change controls impact assessments, and stand-alone actions).

Interface with the Project Teams, MS&T, QC Tech Services, QC Microbiology and Management, Quality Systems, GMP Training, Maintenance and Quality Assurance as a Subject Matter Expert (SME) to provide technical guidance on microbiology testing and environmental monitoring processes.

Communicate effectively with management regarding task completion, roadblocks and needs.

Lead QC Microbiology projects and support site projects, ensuring effective communication and collaboration with Microbiology Analysts/Scientists and Management.

Support management with planning, coordinating, and tracking of QC Microbiology responsibilities including capacity, personnel, equipment, and media/ reagent/test material planning and allocation of resources.

Serve as the Microbiology SME to support and interface with QC Technical Services with the CELabs (Labware) and MODA e-system build.

Serve as a Microbiology SME and actively participate in inspections/audits, site readiness and Health Authority filings.

Initiate, manage, and write investigations and perform root cause analysis.

Perform compendial reviews.

Leadership

Ability to build relationships and foster team cohesion.

Continuous Improvement

Support the continuous improvement plan for site Microbiology operations collaborating with the Microbiology Center of Excellence, in coordination with NPI.

Environmental Health and Safety (EHS):

Ensures compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility.

Works closely with EHS to evaluate hazards and perform risk analysis.

Promotes safe practices and behaviors, verify that EHS rules are implemented and respected.

Compliance

Ensure compliance with cGMPs, USP, Pharm. Eur., JP, ISO, FDA Regulatory Requirements.

Training

Complete necessary training to become a qualified trainer.

Implement, coordinate and conduct effective training and mentoring of analysts, freely sharing knowledge and experience.

Revise and implement new training programs and curricula.

Performs all other tasks, as assigned.?

Working Conditions:

Work requires satisfactory completion of an eye examination to demonstrate 20/20 correctable vision.
Work occasionally requires uniform/PPE to work in a manufacturing, warehouse, or laboratory environment; requires standing, bending, reaching, kneeling, etc.
Work occasionally requires off-shift, extended hours and on-call support as needed to support NPI and validation activities.

Travel Requirement:

Occasional travel may be required.

BMSBL

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