Bristol Myers Squibb Company

Senior Scientist Global Product Quality

Location
Seattle, WA, United States
Posted
Aug 24, 2020
Ref
R1527576
Required Education
Bachelors Degree
Position Type
Full time
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.

About Bristol-Myers Squibb

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.

Position Summary

Bristol-Myers Squibb (BMS) is seeking a Senior Scientist, Global Product Quality. The Senior Scientist will partner with the Global Product Quality Lead (GPQL) to provide direct technical and quality compliance support for early or late-stage cell therapy vector programs. The Senior Scientist will help oversee multiple aspects of the cell therapy vector programs as they move through commercialization readiness activities including commercial filings and approvals as well as life-cycle management activities. The Senior Scientist will assist the Global PQL to develop and roll-out global product quality strategies relating to end-to-end Quality management of clinical / commercial manufacturing, life-cycle improvements (process, analytical), analytical control strategies (methods, specifications), stability, product complaints, and monthly Product Quality Team reviews. The Senior Scientist will support implementation and risk mitigation strategies related to technology transfer, comparability, clinical filings, and life-cycle improvements (as needed). The Principle PQL will be expected to collaborate with QC, QA, Manufacturing, Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs, and other Cell Therapy Development Organizations to ensure regulatory compliance of GMP operations in support of the vector program. This role is stationed in Summit, NJ or Seattle WA and reports to the Director, Global Product Quality, Cell Therapy Vector Programs.

Detailed Position Responsibilities

Provide global product quality support for external manufacturing / partnerships and internal manufacturing operations including developing and maintaining relationships with site QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions.

• Supports the overall product quality strategy based on CMC / TCT deliverables, PD team objectives, life-cycle improvements, and regulatory commitments.

• Provides technical quality expertise and compliance oversight in accordance with global regulatory requirements and internal policies in support of commercial development efforts and life-cycle management activities.

• Supports Global Annual Product Quality Review deliverables that include coordinating with leads of contributing APR sections and ensure timely and compliant execution of the program

• Review and author sections of clinical and commercial regulatory filings as needed.

Serves as a delegate for the Global PQL in CMC/TCT meetings, Development team meetings, and general cell therapy governance meetings.

Coordinates product specific presentations to the Product Quality Review Board / Product Specification Committee and other product quality related cross-functional teams

Supports Quality oversight and delegated launch readiness activities.

Facilitate the timely implementation of global changes with respect to the product. Owns global changes and documentation management activities as required.

Supports product investigations and deviations. Owns and provides input into product assessments

Assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase

Qualifications and Education Requirements

• 7+ years industry related experience

• Scientific background in virology, immunology, viral vector vaccines, analytical methods and stability

• Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products, including viral vectors, plasmids, and viral vaccines.

• Ability to work independently in a high paced team environment, meet deadlines, and prioritize work from multiple projects.

• Strong written, verbal, and organizational skills, and ability to work in inter-disciplinary and cross-functional teams.

• Strong attention to detail and organization skills.

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.