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.

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.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Position Summary

This position leads protocol-driven microbiological method validations and support testing for the Clinical Supply organization and the BMS network of microbiologists. Testing will focus on microbiological testing (bioburden, endotoxin, mycoplasma, minute virus of mouse, rapid sterility, container closure integrity testing). Position will design studies and will seek out and implement new technology, while keeping track of data in electronic systems or notebooks. This position contains a portion of hands-on laboratory-based experimentation and office based data analysis and experimental design, supporting new and existing products in BMS.

Position Responsibilities

• Applies scientific and/or technical skills and functional knowledge to independently conduct and interpret experiments/research/studies in assigned area
• Perform protocol-driven microbiological testing (endotoxin, bioburden, mycoplasma, etc.)
• Based on interpretation of results, designs and executes the next logical step in a series of related experiments/studies.
• Suggests modifications to protocols or alternative protocols, introducing new ideas on how to design, execute, and analyze experiments.
• Uses literature to solve scientific development problems of increasing complexity.
• Consistently acts as a technical point of contact, or SME within own work group/project team/functional area.
• Maintains awareness of technical & business advances impacting their discipline. Contributes to process/technology improvements.
• Provide strategic microbiology support, working directly with development and commercial site leads and other key members of Operations, IT and Quality functions.
• Supports the investigation and implementation of new technologies and methods.
• Supports complex investigations involving microbiological assays, generation of CAPAs and change controls.
• Mentors junior staff and reviews technical data for microbiological assays.
• Provides support for the preparation, review and approval of microbiological methods and validation sections of regulatory filings, as well as responses to regulatory agency questions regarding microbiological assays.
• Participate in internal and external industry forums to understand evolving regulatory expectations and industry best practices.
• Travel to other sites or educational conferences may be required (10%).

Qualifications:

• Requires thorough knowledge of varied aspects or a single specialized aspect of pharmaceutical microbiology or product development.
• Working knowledge of the pharmaceutical development or manufacturing production process.
• Is proficient in scientific/technical writing (e.g., regulatory documents, protocols).
• Advanced experience in pharmaceutical microbiology
• Advanced knowledge of classical, molecular, and/or rapid microbiology methods
• Motivated, adaptable, and results oriented professional
• Capable of mentoring/ directing junior staff
• Knowledge of CMC and related manufacturing guidances and regulations
• Experience in the development and implementation of laboratory procedures, practices and standards
• Ability to build strong, trusting relationships, and work across divisions, diverse business backgrounds and cultures.
• Excellent communication and interpersonal skills with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
• Involved in pharmaceutical industry professional groups and forums
• Experience with working in a matrix environment. Experience interacting with senior leaders and being an influencer/negotiator

Ideal Candidates Would Also Have:

• Experience with endotoxin testing or other microbiological tests
• Experience with low endotoxin recovery (LER) studies

Other Qualifications:

• Bachelor’s or advanced degree in Microbiology or Biology/Biological Sciences.
• Experience (7+yrs) in pharmaceutical microbiology, or equivalent with advanced degree

Working Conditions:

Work is performed in a cGMP compliant laboratory following techniques which require one to maintain a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials. Work may be required on weekdays, weekends, holidays, and during adverse weather conditions. Flexibility to work irregular hours on short notice.

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.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.