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Job Details

Bristol Myers Squibb

Quality Control Method Trending Manager


Development Manager


Devens, Massachusetts, United States

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 in Devens, MA is looking for a Quality Control Method Trending Manager to join our biologics team! As our QC Method Trending Manager, you will support QC methods and instrument performance by monitoring and analyzing invalid rates, using statistical tools, to monitor variation of reference standard data and critical reagents allowing for reaction to adverse trends within the QC Labs ensuring consistent performance. ​

This position is a hybrid role, 50% onsite/remote.

Role Responsibilities:

  • Manage monitoring and analysis of analytical method performance using statistical tools.

  • Provide support during PMI/LES application maintenance related activities.

  • Lead data/analysis requests for APR/APQR, investigations, and analytical method changes within PMI and LES applications.

  • Lead optimization and improvements of analytical method performance data assessments and trending.

  • Manage Manufacturing SPC QC evaluations.

  • Manage QC MP-SAE evaluations.

  • Support investigations related to release and method performance (OOT).

  • Lead data mining, collection, and verification to support local trending and network initiatives.

  • Lead writing of technical reports, APQR, SAE Checklists and MPSAE Checklists.

  • Participates in audit response development and management of response timeline and CAPA identification.

Role Qualifications:

  • Minimum BS degree with 5+ years relevant life-science industry experience (pharmaceutical/biologics) preferably in a QC environment.

  • Knowledge of biologics laboratory settings, GMPs, and support disciplines and the basic principles of each. Knowledge and understanding of regulatory and technical data trending requirements and associated processes.

  • Strong understanding/knowledge of Aegis (Discoverant), JMP, SAP, Sample Manager, LES, Empower and Infinity preferred.

  • Ability to work collaboratively with all employees at all levels.

  • Proficiency in Windows Office Suite, Oracle, SQL.

  • Project management, problem-solving and decision-making skills.

  • Ability to perform well in a team-based environment.

  • Experience determining objectives of significant projects or assignments.



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 Visit 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.