Senior Scientist, Drug Product Champion

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 rich in diversity. 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. Read more: careers.bms.com/working-with-us.

Position: R1589560 Senior Scientist, Drug Product Champion

Manager: Melissa Bentley

Location: USA New Jersey, NBR

Working with Us
Challenging. Meaningful. Life-changing. Those are not 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 will get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. 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. Read more: careers.bms.com/working-with-us

Position Summary

The Product Champion provides technical leadership related to new or existing sterile drug product(s). The Product Champion is responsible for a product(s) at one or more sites.

This position is accountable for key life cycle management product(s), providing specialized expertise necessary to complement site capabilities for critical investigations, process improvement projects, technical transfer projects, etc. 

A product champion is responsible for leading a matrix Drug Product team, driving the drug product book of work, ensuring product robustness and process monitoring.

Key Responsibilities

• Lead Aseptic Drug Product matrix team for a sterile product(s). Represents DP on technical matters at TPT
• Manages DP BOW and risk register.
• Provides assistance to sites to resolve significant quality events, and provides input for complex change controls.
• Informed on Local Change Controls. Endorse Global Change Controls and Responsible for Global Change Control Impact Assessments
• Accountable and responsible for lifecycle documents such as Time Out of Refrigeration (TOR) and Process Description
• Review and co-author sections of the CMC filings and Information Requests (IRs)
• Review and co-author End to End Robustness and End to End Annual Product Quality Reviews. Accountable for robustness action plan.
• Collaborate on TT project definition and support chartered projects.
• Support Technology Transfers, providing input, reviewing/approving key documents.  
• Interact and engage with a core team of specialized experts with necessary capabilities to support the BMS portfolio of products and complement site capabilities.

Qualifications & Experience

Required:

• Knowledge in Biologics/sterile liquid drug products, aseptic processing
• Experience in Biologics/Vaccine Aseptic Drug Product Manufacturing and/or Technology Transfer
• Ability to serve as a technical expert for a Drug Product manufacturing site
• Strong critical thinking, technical writing, and verbal communication
• Demonstrated ability to:
  • Work in a matrix environment and effectively support the decentralized manufacturing function.
  • Build alignment with business partners including analytical, regulatory, and manufacturing regional and site leaders.

Desired:

• Experience in Lyophilization technolog