The Marcus Center for Cellular Cures (MC3) https://marcuscenter.duke.edu/ has an exciting opportunity for a motivated individual to join their team as a GMP Facilities Supervisor in their GMP manufacturing operations located at 2400 Pratt Street, Durham, N.C.
Ensure all Marcus Center for Cellular Cures (MC3) GMP facility systems, equipment and utilities are installed and initially qualified, maintained, repaired and operated in compliance with FDA regulations, applicable procedures and all other regulatory and accreditation requirements. Function as the system owner for facility, equipment and utility systems for the two MC3 GMP Manufacturing facilities: the Robertson GMP Laboratory and the CCBB Laboratory. Oversee all aspects of inventory control for supplies for the MC3 GMP manufacturing facilities.
Ensure all MC3 GMP facility systems, equipment and utilities are maintained, repaired and operated in compliance with FDA regulations, applicable procedures and all other regulatory requirements. Function as the system owner for facility, equipment and utility systems for the two MC3 GMP Manufacturing facilities: the Robertson GMP Laboratory and the CCBB Laboratory. Author SOPs and deviations related to these systems. Perform root cause analysis for deviations and implement robust Corrective Action Preventative Action (CAPA) in a timely manner to prevent recurrence of issues. Manage change control process for all issues related to equipment and facilities. Lead risk assessment analysis for key changes as applicable.
Oversee implementation of IQ/OQ/PQ of equipment. Track Preventive Maintenance (PM) and calibration schedule for all equipment and utility systems. Manage all facility related contractors and vendors, annual contracts and emergency service work. This includes defining the scope of work, ensuring all work is complete in a timely manner and all documentation is thoroughly completed.
Oversee all aspects of inventory control for supplies for the MC3 GMP manufacturing facilities. Establish inventory procedures and policies to ensure proper control, management and reconciliation.
Oversee a team of 3 staff members to support this work. Perform all personnel actions, including interviewing, hiring, and performance management. Manage all facility related contractors.
Collaborate with MC3 GMP Manufacturing team members to create and manage an operations schedule for materials/facilities/equipment/production logistics. Interact on a daily basis with manufacturing personnel to identify and correct deficiencies in equipment or facilitate PM program execution and improvements. Implement equipment improvements through the change control process. Plan and execute projects from inception, design, installation, commissioning and startup.
Provide technical oversight and leadership for key related processes such as mechanical integrity for the facilities, pest control program, etc. Serve as the main point of contact with contract GMP Engineer and maintenance personnel. Oversee facility construction. Act as technical resource and trainer to facilities / maintenance personnel. Interface with regulatory agencies, as needed/upon request by management. Apply Good Documentation Practices (GDP) for all records, adhering to SOPs, and performing self-audits to ensure compliance.
Bachelor's degree in a science, engineering, or related field. Advanced degree MS/PhD is highly preferred.
5 years of experience in the biopharmaceutical or bioprocess industry or equivalent is required with direct experience in process development. Previous direct or indirect supervisory experience is a plus. SKILLS: The ideal candidate will have relevant knowledge and industrial experience in the field of bioprocess development for manufacture of biomolecules and vaccines and will have experience in transferring processes to cGMP facilities for clinical or commercial manufacture. They are expected to possess a high level of skill and experience with key bioprocess techniques including; cell culture, cell line development, bioreactor operation and scale-up, centrifugation (including ultracentrifugation), phase partitioning, column chromatography(size-exclusion, affinity, ion-exchange), tangential flow and normal flow filtration. Expertise in biomolecule (protein, mRNA, DNA) characterization is a plus.
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Job Type: Full-time