Quality Control Microbiology Principal Scientist

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 Quality Control (QC) Microbiology Principal Scientist (EG 120) serves as a subject matter expert (SME) across microbiological test methods and processes, supporting multiple products throughout their lifecycle. The primary focus of this role is to support GMP testing for product release, in-process testing, and transfer/validation activities, while applying a high level of technical knowledge, scientific principles, and regulatory acumen to drive quality outcomes.

This position independently leads and executes method transfers, validations, and verifications, and is responsible for authoring and reviewing associated protocols, reports, and GMP documentation in alignment with regulatory and corporate guidelines. The QC Microbiology Principal Scientist plays a key role in investigations, deviations, CAPAs, and continuous improvement efforts, and actively represents the QC department in cross‑functional teams, product review boards, and both internal and external regulatory inspections.

Serve as a recognized subject matter expert for microbiological test methods and processes across multiple products and product stages. Reviews GMP testing in support of product release, in-process testing, and stability programs for both complex and non‑complex methods on intermediate and finished products. Reviews Microbial Identifications of environmentally isolated organisms using MALDI‑TOF technology and other microbiological platforms. Apply technical knowledge, regulatory requirements, and scientific principles to independently anticipate, troubleshoot, and problem‑solve non-routine and complex microbiological issues.

Lead and execute method transfers, validations, and verifications of in-process, final product, and stability methods. Independently develop, write, and execute methods, protocols, reports, and other related GMP documents aligned with applicable regulatory and corporate guidelines. Perform data verification, data review, and review of GMP documentation to ensure accuracy, completeness, and compliance. Utilize LIMS, ELN, and laboratory data analysis systems to manage, analyze, and report data.

Understand, follow, interpret, and accurately apply Global Regulatory and cGMP requirements across all responsibilities. Represent the QC department in product review boards and regulatory inspections, both internal and external audits. Author and contribute to responses to regulatory requests and health authority inquiries. Review and approve laboratory investigations and deviations, ensuring thorough root cause analysis and appropriate corrective actions. Lead and contribute to the development of CAPAs, change controls, and document revisions in support of quality systems.

Own and contribute meaningfully to complex change controls.

Conceptualize and lead complex projects, change controls, and continuous improvement (CI) initiatives that enhance laboratory efficiency, compliance, and data integrity. Actively participate in and lead Operational Excellence (OpEx) and Continuous Improvement…