The successful candidate is responsible for leading floor activities in the execution of process steps to manufacture clinical and commercial biopharmaceutical products meeting internal and regulatory requirements for domestic and international markets.
Position:The Lead Production Technician will execute the following:
- Demonstrates strong leadership abilities
- Able to motivate team members
- Assign daily tasks to more junior production technicians
- Ensure the completeness and accuracy of manufacturing documentation per approved procedures
- Identify and support the implementation of process efficiencies and areas for improvement
- Provides input into annual performance evaluations of production technicians as applicable
- Demonstrate ability to perform all process steps of upstream or downstream production operations
- Serves as the area supervisor when the Supervisor is unavailable
- Responsible for training junior staff
- Provides clear and concise communication to Supervision/Management.
- Cross-trained in multiple areas within Manufacturing
- Ability to generate SOPs, MPRs, and SPRs for equipment and procedures used in the manufacture of biological based products
- Execution of validation protocols as required
- Perform Steam-In-Place (SIP), Clean-In-Place (CIP), and manual cleaning and sanitization of equipment
- Perform and document production operations according to cGMPs
- Prepare and maintain process equipment used in production support areas including but not limited to raw material weigh and dispense areas, media and buffer prep tanks, parts washers and autoclaves.
- Perform raw material weigh and dispense operations
- Perform cleaning/sterilization operations using parts washers and autoclaves
- Provide support for general maintenance and order of all production areas
- General housekeeping of controlled area
- Other duties as assigned or identified
Bachelors degree in the sciences or engineering and 5+ years relevant experience preferred
MedImmune - 18 months ago
MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial...