Requisition No.: 21558-1
Status: Full Time
Project Duration: 6 months
Scientist for MANUFACTURING / R&D Interface
Project Description: Working within the Small Molecule Pharmaceutical Manufacturing Science & Technology Department, reporting to the Associate Director, responsible for:
- Conducting product and process assessments, collaborating with manufacturing site as well as research and development in drug product process development.
- Providing manufacturing input to the development teams.
- Supporting technology transfer from R&D to the manufacturing sites (or site to site transfers within manufacturing) using principles defined in ICH, FDA, and other regulatory guidelines.
- Monitoring, optimizing and troubleshooting product and manufacturing processes such as granulation, compression, blending, and coating.
- The position is located in New Brunswick, New Jersey USA. The position covers activities on internal and external Manufacturing sites within the Global Product Development and Supply Organization.
- The position works in full compliance with laws, industry regulations, Policies and Procedures including Business Rules as well as the Standards of Business Conduct and Ethics.
Primary objectives include, but are not limited to:
- Support technology transfer related activities from development to launch of new Drug Products with a particular focus on granulation and compression.
- Review and provide input to design and studies for manufacturing processes and specification setting
- Evaluate product performance based on development knowledge and predict manufacturing performance
- Support validation activities at the manufacturing site
- After transfer to manufacturing: analyze trends and criticality in product /process/equipment performance and ensure robust processes are in place and remain in a state of control
- Troubleshooting of manufacturing processes.
• Knowledge of relevant QbD, DOEs, CPP, critical material attributes and CQA's
• Understanding of six sigma tools and principles.
• Is skilled to write and complex study plans and scientific reports.
• Language: English Fluent
• Good communication and technical writing skills, diligent, energetic, fast learner
• Preferred: scale-up knowledge for unit operations