Project Manager II

Essential Job Duties

• In the PDS department, this role would support timelines during the quotation process and engage with BD early-on to ensure successful handoff when contract is signed.
• This individual will help with organizing client visits, both from a due diligence and person in plant prospective.
• This person has a significant role in ensuring financial forecasting and invoicing are as planned, and if not ensures there is a contingency plan to catch up.
• Managing and forecasting project budgets and ensuring change orders are passed on in a timely manner are critical to this job function.
• Manages both internal and external team meetings for assigned clients.
• Provides constant feedback and fast turnaround to internal and external partners.
• Executes client communications, associated with routine engagement, messaging, escalation, and notifications.
• Manages and executes appropriate escalation for client matters within the PDS Management Team, appropriate functions, site leadership and the CDMO BU.
• Serves as site operations business manager, working with site and Supply Chain leadership to: Assure client support prioritization alignment with product forecast and production priorities; Manage Client inventory position, communicate Client’s product necessity in market and their relevant business strategies and plans; Facilitate efforts of Ambassador team to deliver highest levels of service, attention to client inquires, escalation and needs for existing business; Assure connection and information sharing across site functions and with CDMO BU.
• Coordinates efforts to facilitate client product handoff from new product introduction and qualification activities to run-the-business portfolio management duties.
• Orchestrates and assures close management and execution of improve-the-business activity (continuous improvement, deviation investigation and corrective / preventative action efforts) with assigned Clients.
• Executes highly effective routines, tools, templates, and associated guidance for business meeting preparation, setting agendas, and associated standard work which aid client engagement experience.
• Works to ensure safe and compliant execution of activities, including collaboration with EH&S for client safety when on site.
• Executes goals and accountabilities based on agreed objectives and results.
• Collaborate and communicate with other functional areas to promote understanding and achieve strategic objectives.
• Promptly notifies management, the team and Quality leadership of potential issues or problems.

Minimum Education / Experience Requirements

• B.S / B.A. degree in Project Management, Business or a related pharmaceutical sciences field.
• PMP certification preferred.
• 6+ years cGMP experience in solid oral dose pharmaceutical (preferred), biotech or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases to commercial, and / or equivalent amount of experience managing commercial operations or client portfolio management roles.
• Comprehensive understanding of finance – invoicing, financial forecasting, and impact of planning in pharmaceutical or bio-pharmaceutical manufacturing operations.
• 6+ years’ experience and strength in planning, orchestrating, and managing business critical relationships between providers / suppliers and clients.
• Experience working with FDA (Food and Drug Administration) and participating in regulatory agency inspections desirable.
• Strong interpersonal and collaborative / facilitative skills across functions, across internal business enterprise, and externally with multiple clients within a portfolio.
• Proven, effective communication skills, oral and written, ability to drive and be assertive.
• Ability to work independently and in a team setting with minimal supervision.
• Ability to make sound decisions regarding compliance-related issues with minimal supervision; proactive in identifying risks and creating mitigation plans.
• Demonstrated, proven record of personal accountability and responsibility with a delivery-focused mindset.