School of Medicine

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Associate Director, GMP Manufacturing & Operations

Duke Human Vaccine Institute

Occupational Summary: 

As a member of the GMP leadership team, the Associate Director of GMP Manufacturing and Operations will report to the Sr. Director of Product Development and will directly manage the members of the DHVI GMP Operations Team in all activities, including preparation for manufacturing of products, working with Product Development and DHVI leadership for scheduling, preparing manufacturing suite facilities, and working with the DHVI Product Development leadership and staff in ordering, maintaining an inventory of supplies for product manufacture, and facility cleaning. The Associate Director will ensure compliance in all aspects of GMP Operations manufacturing activities.  

The Associate Director will work with the financial staff of the DHVI Product Development Unit and DHVI financial and program teams to ensure adherence to budgets and to directly discuss with Product Development and DHVI leadership all issues related to product development and manufacturing. In addition, the Associate Director will perform other duties as determined by the Sr. Director of Product Development and DHVI leadership. 

The Associate Director is expected to serve as a leading operation expert, providing guidance, recommendations, and judgment for strategic technical issues and decisions. The Associate Director, as an employee of Duke University, will provide senior level oversight, management, and coordination of GMP manufacturing operations and activities. The Associate Director will also assist the DHVI Leadership Team and the Sr. Director of Product Development in developing and refining strategies to accomplish DHVI's mission and will identify and implement the infrastructure necessary to support the successful execution of these strategies. The Associate Director will orchestrate efforts to effectively leverage the participation of a variety of external stakeholders, foster collaborations, and promote the reach and awareness of DHVI. The Associate Director will lead internal Duke staff working for DHVI GMP Manufacturing and oversee technical manufacturing functions to expedite the conduct and completion of GMP projects. The Associate Director will directly report to the Sr. Director of Product Development and indirectly to the DHVI Chief Operating Officer and DHVI Director.  

Work Performed: 

• Directly accountable for GMP manufacturing operations. The role will actively collaborate with Analytical Development, Facilities Manager, GMP Quality Control, GMP Program Management, Regulatory Affairs, and Business Development.  
• Maintains compliance with all federal regulations and safety procedures. This position will also ensure and quantify robust metrics of all existing and new manufacturing campaigns leading to the highest batch success rate possible.  
• Collaborates with process development, Research, sponsors and internal/external manufacturing teams to support New Product Introductions, enabling on-time, right-first-time vaccine technology transfers. 
• Builds and maintains strong and trusting relationships with R&D Leaders, SOM leaders, GMP team leaders, functional management, and other stakeholders to ensure effective communication of plans and issues.
• Stays abreast of scientific developments and trends in manufacturing technologies and participates in external industry/regulatory forums in order to maintain an industry-leading level of subject proficiency.  
• Provides technical/scientific guidance and oversight to project teams facilitating process transfer to GMP operations, work with process development teams to implement improvements in manufacturing. 
• Provides technical/scientific guidance to support investigations, deviations, and corrective actions. 
• Establishes “best practices” and standards where appropriate as related to the manufacturing area of expertise.
• Develops recommendations and options for process improvements.
• Determines staffing requirements and resources needed to ensure the successful execution of Duke's role in GMP manufacturing.  
• Oversees hiring and supervision of Duke personnel assigned to support the GMP manufacturing portfolio.
• Directly manages GMP professional staff, performs personnel evaluations, and assigns work activities for direct reports. 
• Oversees technical efforts, new program planning led by project managers to form project teams, and develops technical project plans and deliverables for approved projects that accurately reflect the technical and compliance related manufacturing needs.  
• Facilitates efforts to identify and engage individuals and organizations, within and outside of the DHVI GMP team, who can provide expert technical input and guidance for each project.  
• Ensures that progress reports on projects are prepared on a regular basis and communicated to the appropriate senior leadership entities (i.e. DHVI leadership, SOM, etc.).  
• Contributes to the development of project strategies, implementation, products, final recommendations, and dissemination plans. 
• Responsible for in vitro transcription, scaling and downstream activities of LNP production and encapsulation, and collaborates on analytical data review and troubleshooting technical issues during manufacturing.  
• Oversees and coordinates Master Cell Bank (MCB) production, Fill/Finish and large-scale transient protein GMP expression.  
• Continuously evaluates how DHVI can reduce the time and expense of protein immunogen or antibody production.  
• Develops plans to support implementation of GMP viral vaccine production and a multiproduct manufacturing workflow in the GMP facility. 
• Works closely with leadership to host tours and interviews that ensure all press releases and other official public communications have received accurate technical information prior to dissemination.  
• Prepares and delivers public presentations regarding DHVI GMP manufacturing efforts at professional and trade meetings and other appropriate venues.
• Oversees the preparation, approval, maintenance and dissemination of key documents pertaining to the operation of the GMP technical manufacturing operations including, but not limited to, guiding principles, policies and procedures, and roles and responsibilities, etc. 
• Interacts closely with members to ensure a consistent understanding of roles, responsibilities, and expectations.
• Plans and oversees the formal evaluation of DHVI GMP technical manufacturing operations performance toward its goals and report on that evaluation to pertinent parties (i.e. DHVI senior leadership, SOM, SAB boards, external auditors, sponsors and key stakeholders).
• Works closely with DHVI faculty, DHVI leadership, Product Development leadership, and the DHVI program team to direct Upstream and/or Downstream aspects of lab scale process development and GMP production for mRNA products including: 
  • Works with DHVI leadership and GMP leadership to evaluate pre-clinical data for each mRNA product under consideration for development. 
  • Works with Process Development team as they develop and execute upstream and downstream techniques for protein and mRNA manufacturing activities. Participates in review of analytical data and troubleshooting technical issues.
  • Actively works with the Analytics Development team to develop product specifications and stability protocols.  
  • Ensures the GMP manufacturing team is successful in process scale up and execution of mRNA production, LNP encapsulation and mRNA/LNP fill-finish under cGMP conditions. 
  • Works with the Quality Assurance team to ensure compliance with Current Good Manufacturing Practice for Phase 1 investigational drugs. 
  • Oversees all aspects of manufacturing processes and manages all aspects of the GMP Operations team. 
• Develops drug product fill/finish vial and label requirements and oversees all aspects of fill/finish activities. 
• Works with the clinical trial development teams and program manager team to ensure adequate amounts of vaccines and adjuvants are produced by the GMP Operations team. 
• Once planning is complete, support goals and plans of DHVI and GMP leadership. 
• Communicates well with the Sr. Director of Product Development and with DHVI leadership regarding all issues and decisions related to this position, financial issues, and the products being developed. 

Data & Regulatory Review and Reporting 

• Facilitates team data review and discussion at group meetings and larger team settings. Provides insight as an external reviewer, and provides perspective to de-risk programs. 
• Leads review of technical development reports; writes and reviews protocols for tech transfer and SOPs for GMP production as relevant, and either presents data to project teams and larger settings or identifies presenters for this purpose. 
• Partners with the Sr. Director of GMP Product Development to evaluate data packages, requests for proposal, scopes of work, and slide decks and provides scientific, technical and regulatory guidance. Also prepares, reviews and edits regulatory documents.  

Professional & Service  

• Supports the preparation of grants and/or contracts and publishes, so as to maintain external reputation in a specific field or expertise area. 
• Mentors junior technical leaders, developing scientific skills and methods and may manage staff. In particular develop a staff cross-trained in all aspects of mRNA product development and in protein and adjuvant manufacture. 

Required Qualifications at this Level:

• Education/Training: Bachelor's degree in a science, engineering, or related field. An advanced degree (Master's, PhD) is preferred.
• Experience: 10 years relevant experience in the biopharmaceutical industry or equivalent.
• Skills:
  • Experience in development of cell culture or protein purification techniques and analytical techniques; experience leading implementation of bioprocess unit operations (bioreactor control and operation, Chromatography, TFF filtration, GE Unicorn software) and/or direct GMP experience is required.
  • Demonstrates innovation in either upstream (cell culture, bioreactor operation including scale up) or downstream purification (chromatography, tangential flow filtration, normal flow filtration) and analytical techniques to support upstream or downstream activities (cell and metabolite analyses, SDS-PAGE, western blot, UV-Vis, colorimetric methods.)
  • Must work independently to develop specific processes or methods in line with strategic program goals.
  • Demonstrated advanced ability in solving complex analytical problems in alignment with strategic project plans.
  • Superior oral and written communication skills.

Preferences

• Manufacturing leadership 
• Protein Upstream & Downstream MFG 
• Mammalian Cell Culture Manufacturing 
• IQ, OQ, PQ 
• SOPs, Deviations, CAPA, Root Cause Analysis 
• LIMS/SAP/other tools 
• Contract MFG (CMO)/Customer relations 
• Project management 
• Facility engineering 
• Vendor management & qualification 
• Supply chain, procurement, and inventory management 

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