Principal Scientist, Drug Product Development to Launch, Pharma MS&T

Bristol Myers Squibb•New Brunswick, NJ

About The Position

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. 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 . Job Function: Provide technical support to the External Manufacturing Organization and (ExM) Contract Manufacturing Organizations (CMOs) as a team leader or individual contributor. Provide technical support as Drug Product Development to Launch representative to the BMS Internal Manufacturing Organization as a team leader or individual contributor. Ensure the transfer of robust manufacturing processes to internal site and/ or CMO from Bristol Myers Squibb (BMS) Product Development (PD)/ Global Product Development and Supply (GPS) or CMO. Ensure robust process performance at CMO during commercial manufacture by using continuous process verification, Operational Excellence (OPEX), etc. to reduce supply risks. Maintain current knowledge of technology to support successful operation of the ExM business unit.

Requirements

Must have in-depth knowledge of the following – Drug Product - recognized as a technical leader and subject matter expert Oral Solid Dosage (OSD).
Experienced with use of statistical software to analyze process related data to determine process capability or for troubleshooting purposes.
Proficient in the technical transfer of products to CMOs and/ or internal sites within budget and according to project timeline.
Demonstrated ability to project manage one or more tech transfer projects with minimal supervision. change control, investigations, process optimization
Excellent verbal, written communications and presentations skills, including excellence at writing complex study plans and scientific reports; informed line management about the critical issues related to product manufacturing and process validation.
In depth understanding of regulations concerning cGMP, manufacturing, validation, quality systems, equipment innovations, upgrades, and instrumentation.
Ability to work on own and as part of a team and to drive issues to resolution.
A degree in science or a related field with a minimum of 7 years relevant experience.
Proven record in pharmaceutical technology, technology transfer, process development, process validation, and manufacturing support/activities.
Experience of statistical software.
Ability to interact at all levels of the organization with proven influencing ability e.g. Regulatory, Supply Chain, CMO, etc. to achieve goals.
Ability to understand business implications of technical decisions.
This position requires up to 20% travel

Responsibilities

Support CMO/vendor selection process and/or internal site selection – preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of Requests for Information (RFIs) and Request for Proposal (RFPs).
Accountable for technology transfer to contract manufacturing organizations.
Support regulatory activities associated with changes to assigned products .
Support operational management of CMO as per Virtual Plant Team (VPT) governance structure.
Provide ongoing technical support to ExM / CMO to ensure compliance and security of supply – metrics review, investigation close-out, change control review, Annual Product Quality Review (APQR) review, process improvement.
Implement / OPEX initiatives as necessary.
Represent MS&T on VPT and project teams.
Works closely with Supply Relationship Manager and project team members in developing strategies and problem-solving efforts.
Where appropriate, engage with brand teams and ExM business units to raise awareness and manage/mitigate risks to product supply, supporting the identification of continuous improvement and business continuity projects.
Product robustness - Technical lead/ product owner for creation of robustness monitoring plan, control strategy
Providing technical oversight to ensure continuous process monitoring for all products within scope.
Communicating output of product performance reviews with VPT and other groups as required
Identifying and executing robustness improvement projects, where required
Support finance with compilation of budget
Supervise work of MS&T Manager / Scientist as required.

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 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.
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.

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