Sr. Project Manager - CDMO, Drug Product, GMP

Job Summary

The Senior Project Manager - Drug Product will coordinate a multidisciplinary project team to assure the accurate and timely completion of all contract writing and managing, ERP, invoicing, designing and implementing project plans, acting as the primary liaison with the project team and client communicating project information to appropriate staff members. The Senior Project Manager may serve as program manager and assist clients with their drug development programs. The Sr. Project Manager may also be called upon to participate in the corporate management process and shall actively engage in and support business development efforts.

On-Site Expectations

• Hybrid role with up to 60% expected on-site, depending on project requirements.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Develops and tracks the project development plan using Smartsheet.
• Identifies and tracks critical path/activities, risks, contingencies and alternatives.
• Communicates out-of-scope activities both internally and externally.
• Implements Change Orders.
• Facilitates team meetings with client and project team; setting-up sub-team meetings as necessary.
• Drives strong interdepartmental collaborations to drive task completion and maintain project timelines.
• Develop a strategy and work with project teams and clients to manage their contract needs.
• Develop and approve proposals and contracts for assigned clients and projects in conjunction with the appropriate project team members.
• Manage contract requirements for each assigned project through ERP and project teams.
• Communicate budget requirements and status to all team members for each assigned project.
• Design, implement timelines, and coordinate a detailed project operational plan for each assigned project.
• Provide project status information both internally and externally.
• Provide project status information both internally and externally at strategic level.
• Provide input and feedback to Senior Management, Line Manager, or individual team members performance.
• Provide direct supervision of Associate Project Manager(s) and Project Managers specific to projects assigned to them.
• Serve as proxy for the management of project managers as needed.
• Assist with business development efforts through ongoing contact with new and assigned clients.
• Assist with regulatory preparation, submission and overseeing project teams within the program.
• Other duties as assigned.

Qualifications

• BA/BS in related field with 5-8+ years pharmaceutical experience.
• Must have 5 years Project Management experience managing multi-disciplinary project teams.
• FDA regulation/ICH Guidelines.
• U.S. Drug Development process.
• Project Management Operations.
• Budgets.
• ERP, QMS, CRM, and MS Suite.

Knowledge, Skills, and Abilities

• Computer proficient.
• Communication (verbal and written) and presentation skills.
• Excellent organizational skills.
• Ability to multi-task.
• Strong negotiation skills.
• Presentation skills.
• Leadership skills.
• Mentoring skills.

Travel Expectations

Travel required to manufacturing locations to host clients and site visits.