Senior Scientist, Vector Analytical Science And Technology (ASAT), Cell Therapy Full-time

Senior Scientist, Vector Analytical Science And Technology (ASAT), Cell Therapy

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But 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.

Position Summary

Function as an analytical expert supporting the Cellular Therapy product portfolio. Successful candidates will have a strong foundation in development of analytical methods supporting the release of viral vectors as well as transfer, validation, and life-cycle management of test methods in a cGMP environment.

Duties/Responsibilities

· Provide viral vector analytical expertise in support of QC lab investigations. This encompasses participating in technical investigations, identifying root cause and providing corrective and preventive actions, including method remediations.

· Support transfer of commercial analytical methods and method validation in compliance with global regulatory requirements.

· Responsible for the stewardship of viral vector analytical methods in the Cell Therapy Quality organization.

· Implement method lifecycle and method maintenance programs to support analytical methods in support of viral vector drug substances.

· Author, revise, and review technical documents such as test methods, SOPs, trend reports, and/or investigation reports as appropriate.

· Lead project, CAPA and deviation/ investigation related tasks and/or continuous improvement efforts.

· Provide support in the authoring of the analytical sections of regulatory submissions, responding to health authority questions and to function as the method validation and method transfer expert during inspections.

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

· Train and mentor others on analytical techniques, methods and procedures.

· Champion and foster a positive and successful collaborative quality culture.

· Perform other tasks as assigned.

Qualifications

· Bachelor's degree in relevant scientific discipline or equivalent is required. Advanced degree preferred.

· 8+ years of relevant analytical experience or equivalent combination of education and experience, preferably in a regulated environment (GMP), cellular therapy, or gene therapy.

· Advanced experience with various analytical methodologies including those related to lentiviral, AAV vectors and other gene delivery platforms.

· 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 in cGMP regulations and application within the Quality Control environment.

· Strong understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of viral vectors, cell therapies, vaccines and/or 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.

· Advance ability to communicate effectively with peers, department management, cross-functional peers.

· Ability to travel to other BMS sites or Partner sites is required.