Senior Process Development Scientist

About the Role

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

Responsibilities

• Manage tasks at an 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, and warehouse environments.
• Exposure to noise, hazardous and non-hazardous chemicals, syringes and needles, and 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.
• Operate equipment such as lyophilizer, HPLC, pH meter, analytical balance, compressed gas cylinders, fume hoods, heating mantles, stirring equipment, temperature controllers, and computer/office equipment.
• Wear protective clothing in lab areas: lab coat, safety glasses, and gloves.
• Lift up to 50 lbs.

Travel

Up to 5%.

Qualifications

• Minimum B.S. in a related scientific field required.
• Minimum 7-10 years of related experience preferred.

Skills & Experience

• 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 and 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 communication 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.