Job Details
Senior Scientist Manager (NPI)- QC Microbiology
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Education and Experience:
Bachelor’s Degree in Pharmacy, Microbiology Science or Biotech
Bachelor’s Degree in Pharmacy, Microbiology Science or biotechnology or equivalent experience
6 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.
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; requiring 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.
Key Responsibilities
Provides technical and microbiological sampling and testing support to NPI-QC Microbiology.
Microbiology testing including, but not limited to, Bioburden, Bacterial Endotoxin Sterility, Biological Indicators, Identifications, Environmental Monitoring, Growth Promotion, incoming media/reagent Quality Control and Media Fill reads.
Cross functional testing duties such as, but not limited to, Gram staining, Identifications, Bioburden, Bacterial Endotoxin Testing (BET), Sterility, Growth Promotion, incoming media/reagent Quality Control, Biological and Endotoxin Indicator Testing, as needed.
Support Microbiology process, equipment and procedure implementation for NPI.
Support transfer across site to site operations.
Support and ensure 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.
Initiate, manage, and execute Change Control documents in support of NPI projects, audit findings, projects, and continuous improvement.
Interface with the PEP21 Project Team, 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 NPI 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 NPI 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 NPI CELabs (Labware) and MODA e-system build.
Serve as a Microbiology SME and actively participate in inspections/audits, site readiness and Health Authority filings.
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
BMS BL
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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