Principal Scientist Global Product Quality

Profile

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.

Join us and make a difference. 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.

The Cellular Therapies Development and Operations (CTDO) organization is seeking a Principal Scientist who will be responsible for the quality oversight of Flow Cytometry methods in support of the Cellular Therapy product portfolio. This position will report into the Global Product Quality group. Successful candidates will have a strong foundation in multi-parameter flow cytometry assays and demonstrated experience working in a cGMP environment.

Responsibilities:


Responsible for the stewardship of late-phase flow cytometry methods in the Quality organization.

Implement method lifecycle and method maintenance programs to support flow cytometry methods used in the release of cell therapy drug products.

Responsible for transfer and validation of methods from Development to Quality Control (QC) laboratories in compliance with global regulatory requirements.

Responsible for authoring relevant analytical sections of submissions, responding to health authority questions and representing the QC function during inspections.

Function as the flow cytometry technical expert for QC labs during internal QC investigations and as the Quality liaison with contract test labs during QC investigations.

Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives. Represent the QC department on cross-functional project development teams.


Qualifications and Education Requirements


BS/MS in a scientific discipline and 10 years experience in multi-parameter (>10-color) flow cytometry execution, training, and technical support. Experience in cellular therapies is preferred.

Strong scientific background and expertise with multiple flow cytometry platforms from analyzers to cell sorters.

Experience in analytical method lifecycle, including method transfer, validation and maintenance. Experience providing training in method execution as well as instrument operation and standardization. Experience with implementing flow cytometry methods in a commercial QC facility is preferred.

Experience in cGMP regulations and application within the Quality Control environment. Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products.

Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team.

Strong technical writing experience (SOPs, Method Validation Protocols and Reports) is required.


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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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