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.
Specifically, the Lead Production Technician will execute the following:
Manufactures clinical and commercial biologics meeting the regulatory requirements of both domestic and international markets
Assigns daily tasks to more junior production technicians
Accurately analyzes and processes scientific data
Ensures the completeness and accuracy of manufacturing documentation per approved procedures
Reviews Master Production Records for accuracy and completion of process steps
Works with more senior manufacturing personnel to improve and optimize manufacturing methods
Evaluates operating procedures for accuracy and efficient operation and makes corrections as necessary
Serves as the lead investigator or primary point of contact for non-conformances, as requested
Serves as the "Subject Matter Expert" in area operations
Responsible for training junior staff
Provides training and operational guidance to more junior staff
Serves as the area supervisor when the Supervisor is unavailable
Provides input into annual performance evaluations of production technicians as applicable.
Provides clear and concise communication to Supervision/Management.
Cross-trained in multiple areas within Manufacturing
Identifies and supports the implementation of process efficiencies and areas for improvement
Expert equipment knowledge to perform trouble shooting and root cause analysis
Demonstrates sound scientific knowledge and understanding of manufacturing processes across all cores areas
Expert knowledge of cGMP standards, and the current code of Federal Regulations (CFR)
Contributes to the development of new concepts, techniques, and standards
Regularly works on routine manufacturing assignments that are very complex in nature, where independent action and a high degree of initiative are required to make recommendations and resolve problems.
Ensures solutions are consistent with organization's objectives
Freedom To Act:
Work is performed without appreciable direction.
Exercises considerable latitude in determining objectives and approaches to assignment.
Initiates work through others
Adheres to Good Manufacturing Practices and standard operating procedures
Interacts regularly with co-workers, senior personnel and supervisor
Contacts are frequent with individuals representing other department, and/or representing outside organizations.
Contacts involve obtaining or providing information or data on matters of moderate importance to the function of the department or which may be of sensitive nature, requiring some explanation or interpretation
Erroneous assignment of task can negatively impact schedule, budget, and/or loss of production lots
Errors in judgment or failure to achieve results would result in the expenditure of large amounts of company resources.
Preferred: Bachelor's degree in the sciences or engineering and 5+ years relevant experience
MedImmune - 2 years ago
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MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial...