Principal Scientist Drug Product Champion - New Brunswick NJ
Principal Scientist Drug Product Champion - New Brunswick NJ
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Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is OnSite at the location detailed in the job post.
Challenging. Meaningful. Lifechanging. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving teams. 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: with Us
Challenging. Meaningful. Lifechanging. 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 highachieving 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.
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.
Duties/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 coauthor sections of the CMC filings and Information Requests (IRs)
Review and coauthor End to End Robustness and End to End Annual Product Quality Reviews. Accountable for robustness action plan.
Collaborate on/Drive 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 subteam TPT meetings etc.
Demonstrates leadership behaviors engaging the right team members to enable decision making and successful project .
Can work independently with little direction.
Additional Qualifications/Responsibilities
Qualifications
Specific Knowledge Skills Abilities:
Indepth 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.
Build alignment with business partners including analytical regulatory and manufacturing regional and site leaders.
Influence areas not under direct control to achieve objectives.
Makes decisions that frequently require developing new options to solve complex problems.
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.
Education/Experience/ Licenses/Certifications:
Bachelors degree required. Master and Ph.D. is preferred but not required
Time spent in advanced degree program may consider as equivalent experience.
Minimum of 9 years of relevant experience.
Travel:
This position requires up to 30 of travel
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other jobrelated duties as requested by management.
If you come across a role that intrigues you but does not perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Required Experience:
Staff IC
Employment Type
Full Time
