Principal Scientist: Pharmaceutical Science & Technology

Role Summary

Principal Scientist: Pharmaceutical Science & Technology. Provide proactive support to enable scientific product understanding of chemistry and process for pharmaceutical products within Technical Operations, ensuring robust processes and change control across APIs and drug products.

Responsibilities

• Establish guidelines and processes to support Nitrosamine Risk Assessments for the product portfolio within the current Nitrosamine working group
• Oversee synthetic chemistry 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
• Provide 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)
• Provide technical research and process knowledge in the implementation of change controls and technical transfers for APIs and drug products
• Monitor process yields, reliability, robustness and associated stability/shelf-life for trends and triggers for improvement via change control
• Collaborate with Quality to support accurate execution of routine process change controls, process validations and analysis of APRs/PQRs for APIs and select drug products
• Provide scientific leadership of API and drug product technology transfers to/from external manufacturing sites to ensure right first-time transfers
• Author technical transfer protocols and reports to support regulatory filings (technical transfers, scale-up and post-approval changes)
• Contribute scientific guidance during process/product deviations, OOT/OOS investigations for APIs and relevant drug products
• Use scientific and statistical analyses to develop process understanding and apply root cause analysis
• Provide written technical justifications for regulatory proposals or regulatory submissions related to externally manufactured products

Qualifications

• Required: Bachelor's degree in Chemistry (Synthetic Organic preferred), Chemical Engineering, or Pharmaceutical Chemistry with 10+ years of experience, or master's with 8+ years, or Ph.D. with 5+ years 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 from R&D to manufacturing
• Strong troubleshooting skills
• Action oriented, able to 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 accomplish tasks/goals
• Ability to quickly change priorities and deliver targeted support
• Ability to present complex scientific information to a business audience
• Excellent verbal and written communication skills, detail oriented, and ability to work productively in an interdisciplinary team environment
• Hybrid work schedule, 3 days in the Bridgewater, NJ office and 2 days remote

Skills

• Technical transfer leadership
• API and drug product process optimization
• Nitrosamine risk assessment
• Extractables/Leachables and Elemental Impurity Analysis
• Change control and deviation management
• Process validation and regulatory filings
• Statistical analysis (e.g., JMP, SAS, Minitab)
• Regulatory knowledge across multiple health authorities
• Technical communication and collaboration across R&D, QA, and external manufacturers

Education

• Bachelor's degree required; advanced degree preferred (Master/PhD)

Additional Requirements

• Hybrid work schedule: 3 days in-office in Bridgewater, NJ and 2 days remote