Senior Scientist, Microbiology

Bristol-Myers Squibb • New Brunswick, NJ

224d • Hybrid

About The Position

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. 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. Our Analytical Strategy and Operations team creates transformative medicines of tomorrow based on the cutting-edge science of today. Working within Global Product Development and Supply this team uses state-of-the art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of life-saving medicines administered to patients in clinical studies. Our team is involved at the earliest stages of Pharmaceutical and Biopharmaceutical product development through the successful commercial launch. As a member of our team, you will get the chance to play a pivotal role to positively impact patients' lives while developing professionally to achieve your own career goals.

Requirements

• Bachelor's degree and 7+ years of experience or master's degree and 4-6 years of experience or PhD and 2-4 years of experience.
• Degree in Microbiology, Biology/Biological Sciences or related field.
• Experience in pharmaceutical microbiology or equivalent.
• Requires thorough knowledge of varied aspects of endotoxin testing, including cartridge based and plate-based systems and automation.
• Requires additional direct applied knowledge of pharmaceutical microbiology used for product development or commercial testing.
• 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 guidance 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.

Nice To Haves

• Extensive direct experience with endotoxin testing as well as other microbiological tests.
• Experience with low endotoxin recovery (LER) studies.
• Prior experience with a broad range of product types, including cell and gene therapy.

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.

Benefits

• Competitive benefits, services and programs.
• Resources to pursue personal and professional goals.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree