Senior Process Development Scientist at Sun Pharmaceutical Industries — Billerica, USA | Base Career

Full Job Posting

Lead 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

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

Senior Process Development Scientist