Principal Scientist, Product Champion

Bristol Myers Squibb • New Brunswick, NJ

9d • Onsite

About The Position

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.

Requirements

• Bachelor’s degree with 9+ years of relevant experience; Master's/Ph.D. preferred.
• Time spent in advanced degree program may consider as equivalent experience.
• In-depth 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
• Ability to work independently (or under limited supervision)
• Demonstrated ability to work in a matrix environment and effectively support the decentralized manufacturing function.
• Demonstrated ability to build alignment with business partners including analytical, regulatory, and manufacturing regional and site leaders.
• Demonstrated ability to influence areas not under direct control to achieve objectives.
• Demonstrated ability to make decisions that frequently require developing new options to solve complex problems.

Nice To Haves

• Experience in Lyophilization technology and ability to serve as technical expert for Lyophilization
• Thorough knowledge of quality systems, Quality by Design, validation principles for product and engineering design and process control fundamentals
• Working competency of Statistical Process Control and related tools is desired
• Experience with regulatory filings and/or Health Authority questions.

Responsibilities

• Lead Aseptic Drug Product matrix team for a sterile product(s).
• Represents Drug Product (DP) on technical matters at Technical Product Team (TPT)
• Manages DP book of work (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)
• 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/Drive technology transfer (TT) project definition and support chartered projects.
• Support Technology Transfers, providing input, reviewing/approving key documents.
• Identifying issues, resolving roadblocks, and informing the team of similar scenarios/learnings from other projects/sites.
• Interact and engage with a core team of specialized experts with necessary capabilities to support the BMS portfolio of products and complement site capabilities.
• Drives DP Strategy and direction within DP sub-team, TPT meetings, etc.
• Demonstrates leadership behaviors, engaging the right team members to enable decision making and successful project execution.
• Can work independently with little direction.
• Report into Product Champion Cluster Lead; may report into TT group or Lifecycle Team Lead as needed with dotted line into Product Champion (PC) team.

Benefits

• Medical, pharmacy, dental, and vision care.
• BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
• 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal