Manager, Upstream Manufacturing
Scope of Function:
Responsible for cGMP Upstream Manufacturing Operations including cell culture and bioreactor processing.
1) Coordinate Upstream Manufacturing activities to ensure projects are performed in accordance with cGMP guidelines and are completed in a manner that meets or exceeds client’s expectations.
2) Interact with other department heads to resolve process and operations issues promptly.
3) Write, review and/or approve written procedures, SOP’s, validation reports, design inputs, exception documents and other cGMP documents.
4) Help to lead technology transfer internally and externally, provide technical support for large-scale non-GMP and cGMP plant operations.
5) Help ensure that staff members are properly trained for their job functions and that the training is documented in cGMP training records.
Education and Skills required:
Education: BS or MS in engineering or biological science or related field.
Experience: Minimum of 5 years experience in cGMP biologics manufacturing. A detailed working knowledge of cell culture and bioreactor production. Phase I-III clinical manufacturing and/or commercial manufacturing. Knowledge of biologics manufacturing, validation protocols, identification and specification of equipment, IQ-OQ, and operations.
Upstream and Downstream Manufacturing, Cell Culture and Process Development. In addition, interacts with Facilities group within the Manufacturing Operations as well as with Project Management, Materials Management, Quality Control and Quality Assurance groups.