Senior Process Development Scientist III

Job Description

Provide support for new product formulation, process development, transfers into manufacturing, and continuous improvement of existing processes.

• Manage tasks at independent level and contribute to cross functional project management teams
• Design experiments using Quality by Design principles, execute and author reports in support of:
• Formulation, aseptic filling and lyophilization development of new products
• Continuous improvement, troubleshooting and investigations of existing processes and products
• Process transfers into manufacturing
• Perform analytical testing in support of product development studies
• Prepare cGMP documents such as SOPs, batch records and protocols
• Design, execute and write technical reports to support FDA filings
• May direct the work of junior Process Development staff
• Other duties as assigned

• Office
• Lab
• Warehouse
• Exposure to noise, hazardous and non-hazardous chemicals, syringes and needles
• toxic metals

• Stand, sit, walk, use hands and fingers to handle or feel, reach with arms and hands
• Talk or hear
• Close, and color vision; depth perception, ability to adjust focus
• Use of repetitive motion