Senior Scientist MLC Biologics Global Quality Analytical Science and Technology

Profile

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.

Principle Objective of Position

Method Life Cycle Biologics group is seeking a senior scientist with strong hands-on experience and advanced data analysis in cell based potency, immunoassays and impurity assays with demonstrated technology transfer and trouble shooting experience for commercial methods. The Senior Scientist will collaborate across BMS sites with Analytical Science and Technology, Manufacturing Science and Technology, Analytical Development, Global Quality teams as a technical project team member and subject method expert to execute the network analytical controsl and commercial strategies for drug substance and drug product methods throughout the product life cycle.

The Analytical Sciences & Technology group is committed to supporting our global biologics analytical network with reliability, integrity, active engagement, and cross functional collaboration.

Major Duties and Responsibilities


Provide technical leadership for all analytical activities for the development, validation and transfer of test methods to Quality Control laboratories both within and outside BMS.
Establish method validation strategy and partner with analytical development and quality control for successful execution of method validation prior to commercial use.
Perform periodic review of method performance and develop strategy and execution plan for required remediation/revalidation activities.
Responsible for support of maintenance critical reagent supply for assigned methods.
Contribute to analytical CMC strategy including specifications for binding and potency assays and impurities.
Provide technical expertise for method readiness, transfer, performance and trouble shooting in commercial environment and maintaining global analytical business processes that facilitate the seamless advancement of projects from late phase development, to licensure and throughout the commercial lifecycle.
Work closely with all AS&T team members to understand their deliverables to establish and implement suitable work processes
Method development, method remediation and pre-validation to improve strategic outcomes or changes to commercial landscape


Physical Demands


This role requires office work, biochemical laboratory work, computer work, group meetings, and thus involves the following

Sitting, standing, walking, working with analytical instruments, repetitive motion including bending and lifting small containers/equipment


Work Environment


This role requires office work, teleconferencing, computer work, leading meetings and thus involves the following

Working in open office environment, working in laboratory, working alone, working with/around others


Supervisory Responsibilities


This role is an individual contributor and will not have direct reports


Required Knowledge/Skills/Qualifications

Education:

Ph.D. >4 years, MS >10 years, BS >13 years

Experience/Knowledge:

Bio-therapeutic development & industry experience

Skills/Competencies:


Demonstrated experience with cell based bioassays (potency) immunoassays and impurities in biologics process development and/or manufacturing environment. Method Life Cycle experince is preferred.
Demonstrated experience of robust bioassay method development qualification and/or validation with extensive familiarity with USP/ICH guidelines.
Experience of working with colleagues at remote sites and ability to influence using collaborative approach to design the scientific and technical aspects of analytical strategy for commercial readiness of specific methods.
Experience analyzing data generated by others and identifying areas for method improvements.
Strong written and communication skills and will have experience working in a matrix organization.
To be successful in this role, the candidate must excel at collaboration with partners, customers, and team members, operate with integrity, and proactively facilitate the continuous improvement of systems and culture.


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.

Company: Bristol-Myers Squibb

Req Number: R1526434_EN

Updated: 2020-07-24 00:00:00.000 UTC

Location: Devens,Massachusetts

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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