Scientist Jobs

About The Position

Requirements

• Minimum B.S. in related scientific field required
• Minimum 7-10 years related experience preferred
• Able to work with external contractors to find new technology, equipment or solutions to process issues
• Process validation experience
• Cleaning validation experience
• Analytical hands-on experience with techniques such as HPLC, Karl Fischer, DSC, and spectroscopic techniques
• Experience working in a cGMP environment
• Process development experience and manufacturing process investigation skills
• Strong technical writing skills and resourceful problem solving skills
• Ability to work independently and as a member of a cross functional team
• Excellent verbal, written and interpersonal communications skills
• Strong attention to detail and ability to manage multiple assignments concurrently
• Able to lead cross functional teams to design experiments and address process issues

Nice To Haves

• Experience with parenteral formulation, lyophilization and sterilization techniques preferred
• Experience with aseptic techniques in a clean room environment is highly beneficial
• Understanding of Quality by Design principles and statistics is preferable

Responsibilities

• 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