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 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.
- Up to 30% travel
Qualifications & Experience: Required:
- 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.
Desired:
- 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.
Compensation Overview:New Brunswick - NJ - US: $123,580 - $149,752
The starting compensation range(s) for this role are listed above 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.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- 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 include:Paid Time Off
- 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)
- 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 for employees 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 Years 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.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
