Director, Project Management

5/31/22

Nashville, TN

1700

Our client is hiring a Director, Project Management to join our team. The Director of Project Management is a technically knowledgeable leader with proven abilities to lead project teams. The Director will be a hands-on leader with a passion for driving results in a dynamic customer focused environment.

This leader will coordinate all projects related to pre-formulation, formulation development, analytical development, cGMP manufacturing and stability studies for drug product development from clinical to commercial manufacturing. This person will be the leader of the project management platform providing continuous improvement, by providing strategic direction, setting clear expectations and metrics. This role will be accountable for managing our partners programs internally and reporting back to our partners. This position requires a scientific background with global expertise in current Good Manufacturing Processes (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and clinical and commercial pharmaceutical manufacturing. The CDMO and CRO environment is fast-paced and requires an elevated level of multi-tasking skills that is essential to the success of this position.

Responsibilities

  • Provides operational leadership for customer projects in drug development and manufacturing.
  • Actively engages in and supports new business development opportunities.
  • Ensures timely and effective communications with business partners and leadership teams.
  • Prepares meeting agendas, manages, and leads meetings, tracks action items via meeting minutes, and coordinates team activities through use of project management tools.
  • Develops a communication plan that will ensure seamless communication with the project team, customer, project steering committee, and all stakeholders.
  • Fosters a positive customer experience and relationship, by providing industry leading customer service.
  • Collaborates with internal key stakeholders to drive superior results.
  • Establishes and manages project scope and work plans.
  • Ensures collaboration with appropriate team members across different functions for driving business decisions and client communications.
  • Manages changes in scope of projects through change orders.
  • Works closely with extended team to ensure project deliverables meet customer expectations and timelines.
  • Manages multiple client projects ensuring on-time, within-budget delivery.
  • Accountable for hosting client visits to site. Ensures that all personnel involved with these activities on site are fully briefed regarding the nature of the visit, the customer and their business interests.

Requirements

  • A Bachelor’s Degree in scientific or engineering required; Master’s degree and/or PMP preferred.
  • Experience (10+ years) managing cross-functional teams or projects in a CDMO, pharmaceutical development, or GLP/GMP manufacturing setting.
  • Knowledge of project management techniques and tools.
  • Excellent leadership, written and verbal communication skills and ability to influence others.
  • Excellent negotiation and facilitation skills, with strong customer-service focus.
  • Strong aptitude for technical comprehension enabling rapid learning in a highly regulated environment.
  • Ability to lead multi-disciplinary project teams.
  • Strong understanding of pharmaceutical product development and manufacturing.
  • Strong knowledge of FDA regulation/ICH guidelines, U.S. drug development process and project management practices.
  • Proficiency in Microsoft Office programs including Word, Excel, MS Project and MS Teams.
  • Proficiency with ERP, CRM, and Documentation Systems.


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