| 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
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