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