Principal Scientist: Pharmaceutical Science & Technology

Principal Scientist:
Pharmaceutical Science & Technology

Job Description Job Alerts Link Apply now Principal Scientist:
Pharmaceutical Science & Technology

Job Location:

Bridgewater, New Jersey, USA Job Requisition

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.

Technical Operations is the organization responsible for ensuring Global Manufacturing & Supply continuity for Bausch Health’s Rx, Generic, and Global Expansion Products. Technical Operations utilizes QbD approach to ensure our pharmaceutical products are scientifically robust, manufactured under control and remain in a constant state of validation throughout their product lifecycle in order to maintain a consistent supply of safe and effective products to patients .

The Principal Scientist of Pharmaceutical Science and Technology provide proactive support to enable scientific product understanding of chemistry and process.

Responsibilities include:

• Establishing guidelines and processes to support Nitrosamine Risk Assessments for the entire product portfolio within scope of current Nitrosamine working group
• Be responsible for the synthetic chemistry oversight and transfer technology for active pharmaceutical ingredients (APIs) and drug products
• Develop and maintain subject matter expertise in Extractables/Leachables and/or Elemental Impurity Analysis guidelines and requirements
• Provides technical support to R&D during API and drug product manufacturing scale-up, process/packaging validation and launch of new products at external manufacturing organizations (EMOs)
• Provides technical research and process knowledge in the implementation of change controls and technical transfers for APIs and drug products
• Monitors process yields, reliability, robustness and associated stability/shelf-life for trends and triggers for improvement via change control
• In collaboration with Quality, supports the accurate execution of routine process change controls, process validations and the analysis of Annual Product Reviews (APRs)/Product Quality Reviews (PQRs) for APIs and select drug products
• Providing scientific leadership of API and drug product technology transfers to/from external manufacturing sites to ensure right first-time transfers
• Authors technical transfer protocols and reports to support regulatory filings (technical transfers, scale-up and post-approval changes)
• Contributes scientific guidance during process/product deviations, out-of-trend/ out-of-specification (OOT/OOS) investigations for APIs and relevant drug products
• Use scientific and statistical analyses to develop process understanding. Uses knowledge further in root cause analysis investigations
• Provides written technical justifications for regulatory proposals or regulatory submissions related to externally manufactured products

Requirements:

• Bachelor’s degree in in Chemistry (Synthetic Organic preferred), Chemical Engineering, or Pharmaceutical Chemistry with 10+ years of experience, or master’s degree with 8+ years of experience, or Ph.D. with 5+ years of experience in Pharmaceutical or API Technical Services encompassing Technical Transfer, Technical Trouble Shooting and Process Optimization
• CMC Subject Matter Expertise across a broad range of synthetic processes and pharmaceutical dosage forms
• Demonstrated industry experience supporting approved commercial products
• Direct experience with transferring technology R&D to manufacturing
• Strong trouble shooting skills
• Must be action oriented, make informed decisions and be self-motivated
• Working knowledge of databases. Ability to utilize JMP SAS, Minitab, or other statistical analysis software as needed
• Understanding of CMC regulatory requirements and technical risk management
• Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
• Ability to detect and resolve problems, own decisions, and…