M-F Full Time
This individual is responsible for all cGMP compliant Manufacturing and Facility Operations including cell culture, bioreactor operations, protein purification and final filling, Facilities and Materials Management.
Key areas of accountability include directing the activities of the responsible upstream and downstream manufacturing departments to assure projects are performed and completed in a manner that is acceptable to clients and GBI; ensures that operations departments follow cGMP, SOPs, and safety procedures as necessary and also ensures that all operations employee are properly trained for their job functions and that the training is documented in CGMP training records. It is expected that this individual will be intimately involved and hands-on activities for all GMP manufacturing, Facilities Operations and Materials Management group.
The Director of Manufacturing Operations will collaborate with Business Development, Process Development, Project Management, RA/QA/QC, and both existing and prospective clients to meet the requirements of each project. This individual will also be responsible for schedules for manufacturing activities and also prepare, review and approve written procedures, SOP’s, batch records, validation and other documents.
Candidate will have a MS or Ph.D in engineering or biological science or related filed and a minimum of ten years in cGMP biologics manufacturing. Candidate must have a detailed working knowledge and hands-on experience of cell culture, bioreactor production, chromatography, ultrafiltration, and filling operations, and Facilities Operations. Experience in biologics manufacturing, preclinical, Phase I-III clinical manufacturing and/or commercial manufacturing is critical for this position. Knowledge of biologics manufacturing plant design, validation protocols, identification and specification of equipment, and operation are important.
Goodwin Biotech - 11 months ago