Senior Process Development Scientist

Job Summary

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

Area Of Responsibility

• 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

Work Conditions:

• Office


• Lab


• Warehouse


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

Physical Requirements:

• 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


• Operates Lyophilizer, HPLC, pH meter, analytical balance, compressed gas cylinders, fume hoods, heating mantles, stirring equipment, temperature controllers, and computer/office equipment


• Requires wearing protective clothing in lab areas - lab coat, safety glasses, and gloves


• Lift up to 50 lbs.

Travel Estimate

Up to 5%

Education and Job Qualification

• Minimum  B.S. in related scientific field required

Experience

• Minimum 7-10 years related experience preferred


• Able to work with external contractors to find new technology, equipment or solutions to process issues


• Experience with parenteral formulation, lyophilization and sterilization techniques preferred


• Process validation experience


• Cleaning validation experience


• Analytical hands-on experience with techniques such as HPLC, Karl Fischer, DSC, and spectroscopic techniques


• Experience with aseptic techniques in a clean room environment is highly beneficial


• Experience working in a cGMP environment


• Understanding of Quality by Design principles and statistics is preferable


• 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