GMP FACILITIES SUPERVISOR - MARCUS CENTER for CELLULAR CURES

Duke University Health Systems - Durham, NC

Full-time

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.

Occupational Summary

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.

Job Description

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.

Preferred Skills

  • Knowledge about basic principles of operation for process and utilities equipment such as pumps, piping and valves, heat exchangers, agitators and mixing equipment
  • Excellent communication, documentation and technical writing skills.
  • Experience working in a GMP environment, with a working knowledge of change control and investigations
  • Demonstrated project and people management skills

Minimum Qualifications

Education

Bachelor's degree in a science, engineering, or related field. Advanced degree MS/PhD is highly preferred.

Experience

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.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Job Type: Full-time

Experience:

  • relevant: 5 years (Required)

Education:

  • Bachelor's (Required)