- Act as the primary point-of-contact between the clients & internal stakeholders
- Join a World Class Pharmaceutical manufacturing partner in growth mode
About Our Client
This client is a Contract Development & Manufacturing Organization dedicated to bringing pharmaceutical ideas to life by offering expertise in high potent drug development, a drive to enhance performance, a passion for perfection, and a commitment to bringing our pharmaceutical clients through their whole journey.
- Primary point-of-contact for client programs assigned; responsible for building and maintaining quality relationships with key stakeholders resulting in valued and trusted relationships, client satisfaction and continued strategic business opportunities.
- Develop detailed project plans, including regular monitoring and updating of project schedules using Smartsheet, Microsoft Project, or similar software to meet or exceed clients' expectations; project plans are to be mutually-defined with the client.
- Will be responsible for multiple programs and/or projects at any given time.
- Develop project risk management plans in collaboration with project team members: identifying major project risks, determining impact to project scope and schedule, and defining triggering events to prompt execution.
- Develop communication plans for defining communication channels between internal and external stakeholders, establishing and leading regularly scheduled project status meetings and communicating as needed in response to issues as they arise during project execution.
- Provide regular program status updates to clients and management that shall highlight key milestones, issues and/or risks, schedule, and costs.
- Conduct thorough review and assessment of all new and existing project proposals and/or quotes; generate new proposals and/or scope changes, as needed.
- Forecast project revenue on a monthly, quarterly and annual basis.
- Work with the project team to formulate recommendations for value added services based on project objectives and regulatory requirements.
- Collaborate and communicate 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 and communicate with Engineering/Operations to ensure appropriate generation of GMP documentation including batch records, specifications, etc.
- Collaborate and communicate with the Analytical Laboratory to ensure necessary client testing is developed, validated/verified, specifications are generated and product is tested per a mutually-defined timeline.
- Responsible for client contract adherence and Purchase Order management.
- Collaborate with supervisor and Site Leadership Team to ensure all activities defined herein, meet or exceed clients' expectations, including the establishment and monitoring of project budgets.
- Identify key project challenges and issues within a timely manner and determine effective resolution through cross functional collaboration; recommend appropriate corrective action as appropriate.
- May have other duties and responsibilities as required.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
- Bachelor's degree in the life sciences, engineering, business and/or related discipline required.
- At least five (5) years' 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 would be advantageous.
- PMP certification preferred.
- Positive attitude, self-motivator, strong attention to detail, excellent organizational and project management skills required.
- Strong interpersonal skills with the ability to negotiate with various stakeholders to reach consensus; experience in conflict management and resolution is advantageous.
- Knowledge and experience of U.S. FDA Regulation 21 CFR Part 210, 211 and ISO 13485:2016 is preferred.
- Advanced in Microsoft Office: Word, Excel and Project required, Smartsheet is advantageous.
- Easily adaptable to ERP system(s).
- Ability to communicate effectively with all levels of employees and management.
What's on Offer
- Highly visible role with opportunity for career growth/trajectory
- Leadership role with direct reports
- WFH capabilities/flexibility
- Competitive compensation package
- Comprehensive benefits package