Augustbioservices9mo ago

Director, Project Management

United States·NashvilleFull-Timeexecutive

OtherProject Management

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The Director of Project Management coordinates all projects related to client programs spanning across pre-formulation, formulation development, analytical development, cGMP manufacturing and stability studies for drug product development from preclinical to commercial. The Director of Project Management serves as the leader of the project management platform driving continuous improvement, by providing strategic direction, setting clear expectations and employing performance metrics to track delivery against client expectations. This role is accountable for managing our client programs internally and directly engaging with our clients throughout the life of the program. This position requires a scientific background with global expertise in current Good Manufacturing Processes (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), a comprehensive understanding of the drug development lifecycle and of clinical and commercial pharmaceutical manufacturing. The CDMO environment is fast-paced and requires an elevated level of multi-tasking skills that is essential to the success of this position.

Provides operational leadership for customer projects in drug development and manufacturing

Actively engages in and supports new business development opportunities

Ensures timely and effective communication with business partners and leadership teams

Manages a team of PMs who are directly assigned as the primary liaison for specific client programs

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 alignment amongst the project team, client, internal subject matter experts, and all stakeholders

Fosters a positive client experience and relationship, by providing industry leading customer service

Establishes and manages project scope and work plans

Ensures collaboration with appropriate team members across different functions for driving business decisions and client communication

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

A bachelor’s degree in science or engineering required; master’s degree and/or PMP preferred.

Experience (10+ years) managing cross-functional teams or projects in a CDMO or pharmaceutical development or 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 Quality Management Systems

Prolonged periods sitting at a desk and working on a computer.