Principal Scientist, Drug Product Development to Launch
Company: Bristol-Myers Squibb
Location: New Brunswick, NJ, USA
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 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.
Duties / 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.
Required Competencies
Must have in-depth knowledge of the following – Drug Product: recognized as a technical leader and subject matter expert in 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.
Knowledge of change control, investigations, process optimization.
Excellent verbal, written communications and presentations skills, including excellence at writing complex study plans and scientific reports; ability to inform line management about 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.
Required Qualification(s) and Desired Experience
PhD in Science or a related field with 4–6 years of relevant experience, a Master’s degree with 6–9 years, or a Bachelor’s degree with 9–12 years of relevant experience.
Proven record in pharmaceutical technology, technology transfer, process development, process validation, and manufacturing support/activities.
Experience with statistical software.
Ability to interact at all levels of the organization with proven influencing ability (Regulatory, Supply Chain, CMO, etc.) to achieve goals.
Ability to understand business implications of technical decisions.
Travel
Up to 20% travel.
Compensation Overview
New Brunswick, NJ – US: $123,580 – $149,752.
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.
Equal Employment Opportunity Statement
Bristol Myers Squibb is an equal‑opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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