Project Manager

SUMMARY

Project Manager is responsible for the success of Contract Development and Manufacturing Programs by execution of project plans to exceed expectations and provide excellent client service. These positions act as the primary point of contact between their clients and internal stakeholders to ensure that all scope, schedule, resource, and budgetary requirements are met. This position will report to the Senior Project Manager with a dotted line to the Putnam Site Lead.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Single point-of-contact for assigned client programs; responsible for building and maintaining quality relationships with key stakeholders resulting in valued and trusted relationships, client satisfaction and continued strategic business opportunities.
• Lead development of all new and existing project proposals and/or quotes; generate scope changes, as needed.
• Develop detailed project plans, including regular monitoring and updating of project schedules to meet or exceed clients’ expectations; project plans are to be mutually defined with the client and balanced with internal priorities.
• Will be responsible for multiple programs and/or projects at any given time.
• Develop project risk management plans in collaboration with project team members, identify major project risks, determine impact to project scope and schedule, and define triggering events to prompt execution.
• Develop communication plans for defining channels between internal and external stakeholders, lead regularly scheduled project status meetings and communicating as needed in response to issues as they arise.
• Prepare documentation and deliverables for regular program status updates to clients and management, highlighting key milestones, issues and/or risks, schedule, and costs.
• Responsible for forecasting project revenue on a monthly, quarterly, and annual basis based on confirmed orders and product schedules.
• Work with the project team to formulate recommendations for value added services based on project objectives and regulatory requirements.
• Collaborate with Supply Chain to ensure 1) appropriate material procurement activities occur, and urgency is understood, 2) determine plan for excess and obsolete material disposition.
• Collaborate with Engineering/Operations to ensure appropriate generation of GMP documentation including batch records, specifications, etc.
• Collaborate with the Analytical Team to ensure client testing is developed, validated/verified, specifications are generated, and product is tested per timeline.
• Responsible for client contract adherence and Purchase Order management.
• Collaborate with internal stakeholders to ensure all activities defined herein meet or exceed clients’ expectations, including the establishment and monitoring of project budgets.
• Identify key project challenges to recommend risk mitigation.
• Must be comfortable and able to present in front of an audience, as well as interfacing directly with clients.
• May have other duties and responsibilities as required.

SUPERVISORY RESPONSIBILITIES

This position may have supervisor responsibilities, and also provides leadership to teams or groups formed for specific project objectives.

QUALIFICATIONS

• Bachelor's degree in the life sciences or engineering, is preferred, Masters is a plus.
• Should have 5-10 years of experience in a project management or project planning role, preferably in the Pharmaceutical or Medical Device industry(s).
• Knowledge of pharmaceutical contract-based R&D and manufacturing is preferred; knowledge and experience of U.S. FDA Regulation 21 CFR Part 210, 211 and/or ISO 13485:2016 is required.
• Extensive experience in managing multiple complex projects, programs, and/or portfolios in parallel.
• Experience in building long term partnerships with clients, based on a combination of technology platforms.
• Strong financial background or education, with experience in managing budgets, costs, and profitability. MBA is helpful.
• PMP certification is preferred.
• Advanced in Microsoft Office: Teams, Word, and Excel. PM software experience is required.
• Easily adaptable to ERP system(s) and advanced Project Management tools and systems.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to walk, talk, and hear. The employee is occasionally required to stand for extended periods of time. The employee is frequently required to sit; reach with hands and arms.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may occasionally be exposed to moving mechanical parts, fumes or airborne particles, active pharmaceutical ingredients and other raw materials necessary for the completion of such projects.