Senior Process Development Scientist III

Job Description

Provide support for 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 10 lbs.

Travel Estimate Up to 5%

Education and Job Qualification

• Minimum B.S. in related scientific field required

Experience

• Minimum 4-6 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
• Process validation experience is a plus
• 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.

The presently-anticipated base compensation pay range for this position is $102,500 to $113,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.