Principal Scientist, Product Champion

About the role

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.

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.

Responsibilities

• Lead Aseptic Drug Product matrix team for a sterile product(s).
• Represent Drug Product (DP) on technical matters at Technical Product Team (TPT).
• Manage DP book of work (BOW) and risk register.
• Provide assistance to sites to resolve significant quality events, and provide input for complex change controls.
• Stay informed on Local Change Controls; endorse Global Change Controls and be responsible for Global Change Control Impact Assessments.
• Be 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 and drive technology transfer (TT) project definition and support chartered projects.
• Support Technology Transfers by providing input, reviewing/approving key documents, identifying issues, resolving roadblocks, and sharing learnings from other projects/sites.
• Interact and engage with a core team of specialized experts to support the BMS portfolio of products and complement site capabilities.
• Drive DP Strategy and direction within DP sub-team and TPT meetings.
• Demonstrate leadership behaviors, engaging the right team members to enable decision-making and successful project execution.
• 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.
• Up to 30% travel.

Requirements

• Bachelor’s degree with 9+ years of relevant experience; Master's/Ph.D. preferred. Time spent in advanced degree program may be considered as equivalent experience.
• In-depth knowledge in Biologics/sterile liquid drug products and 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 skills.
• 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.

Skills

• Experience in Lyophilization technology and ability to serve as a 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.
• Experience with regulatory filings and/or Health Authority questions.

Pay

New Brunswick - NJ - US: $123,580 - $149,752. The starting compensation range(s) for this role are listed for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 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.
• Work-life Benefits:
  • Paid Time Off for US Exempt Employees: Flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio employees).
  • Paid Time Off for Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Based on eligibility, additional time off may include 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 Year's Day.

All global employees (full and part-time) who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

Schedule

This role may require up to 30% travel.

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type will be determined by the nature and responsibilities of the role:

• Site-essential roles: Require 100% of shifts onsite at your assigned facility.
• Site-by-design roles: May be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
• Field-based and remote-by-design roles: Require the ability to physically travel to visit customers, patients, or business partners and attend meetings on behalf of BMS as directed.