Project Manager

Responsibilities

• Determine and maintain project timelines, estimated level of effort, and resource/budget requirements
• Prioritize project activities, ensuring deadlines are achieved and the project team effectively communicates about progress and obstacles, both within the project team and to stakeholders
• Track all project related activities to ensure successful completion of objectives
• Recognize and encourage behaviors that contribute to teamwork and improve outcomes, leveraging the unique talents of each project team
• Prepare meeting agendas, manage and lead video/teleconferences, track action items via meeting minutes, and coordinate team activities as assigned
• Develop a communication plan that will ensure seamless communication with the project team, customer, project steering committee, and all stakeholders
• Actively engage in and support new business development opportunities
• Manage changes in scope of projects by requests of change orders via Requests For Proposals
• Manage client relationships ensuring on-time project execution and 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 business enquiry, the customer and their business interests

Requirements

• A Bachelor’s Degree in scientific or engineering discipline required
• Experience (5+ years) managing cross-functional teams or projects in a CDMO, pharmaceutical development, or GLP/GMP manufacturing setting, or analogous technical industry. 7-12 years preferred
• Demonstrated experience in the use of process improvement methodologies, such as Lean or Six Sigma, or related practical approaches (5 Whys, 6 Ms, 7 Wastes, brainstorming, 2x2 prioritization matrix, Exploratory Data Analysis, etc.)
• Ability to understand complex business processes and adapt solutions to meet the needs of the business
• Proven analytical skills, with the ability to approach problems logically and systematically
• Knowledge and experience in the application 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
• Understanding of pharmaceutical product development and manufacturing
• Knowledge of FDA regulation/ICH guidelines, U.S. drug development process and project management practices preferred
• Proficiency in Microsoft Office programs including Word, Excel and MS Project
• Proficiency with Smartsheet, ERP, CRM, and Documentation Systems