Senior Principal Scientist Process Analytics
Bristol Myers Squibb - Devens, MA
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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.Position SummaryProcess Analytics & Method Characterization (PA) is a part of the Biologics DS MST organization and provides analytical support for commercial Drug Substance (DS) Biologics programs. PA performs in-process tests for DS characterization and detection of impurities, for products manufactured at the BMS Devens MA facility, as well as products manufactured at other sites in the network.The Senior Principal Scientist PA will lead a team of scientists responsible for analytical testing of in-process samples and method improvement, e.g., via automation and participation in innovative PAT initiatives. The role is responsible for managing timely completion of sample testing requests, and will be POC for stakeholders in Biologics Development, Analytical Sciences and Technology (AST) and Quality Control (QC), and support tech transfer of methods, validation and GMP (release) testing.The successful candidate is a recognized analytical methods SME, with previous managerial experience. Extensive experience with liquid chromatography and other separation methods, impurity assays, protein quantitation and glycan analysis, is expected. The position reports to the Associate Director PA & Methods Characterization.Key ResponsibilitiesCoordinate analytical testing of in-process samples in support of commercial manufacturing and PPQ campaigns, ensuring timely completion of testing requestsTake responsibility for PA laboratory operations - ensure compliance with safety and cleanliness standards (5S), instrument maintenance, data management/analysis, etc.Maintain and track testing schedules, analyst training and assay performance matricesDrive PA efforts for method improvement and support team members working on PAT projectsFunction as POC for Biologics Development, AST and QC and provide support for tech transfer, method validation and GMP testing, when neededCoordinate testing required for Drug Product (DP) stability studiesSupport HA filings / CMC sectionsManage team of analytical scientists, guide direct reports project and lab activities, and career development objectivesQualifications & ExperiencePhD in STEM field with 6+ years of experience, MS in stem field with 9+ years of experience, BSc in STEM field with 12+ years of experience (e.g., biochemical engineering, biochemistry or equivalent)Recognized SME for analytical characterization of protein biologics (extended characterization and impurity testing)Experience with method validation and GMP (release) testingExperience supporting HA filings / CMC sections desiredExperience with assay automation desiredExperienced people managerExperience contributing to diverse multi-function project teamsInnovative and interested in opportunities to expand knowledge baseAppreciation of teamwork and diversityAround 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 [Click Here to Email Your Resumé]. Visit /eeo-accessibility to access our complete Equal Employment Opportunity statement.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Created: 2025-10-04