Senior Project Manager - R&D (OH or NJ)
Cleveland, OH 44146
Senior Project Manager – Pharmaceutical Product Development / R&D
Our client is a global leader in developing and getting to market pharmaceutical drug products. Over 2billion in revenue and over 40 manufacturing and research centers in the world they continue to be at the forefront of innovation and scientific breakthroughs.
The R&D Sr. Project Manager utilizes pharmaceutical development knowledge, skills, tools, and techniques to plan, monitor, execute, and control complex development programs. The R&D Sr. Project Manager will work with external partners on co-development and under license projects as well internally developed projects and will be responsible for developing program budgets, project timelines, and risk registers, as well as ensuring that project execution is performed in accordance to an approved project plan. The individual will drive projects across multiple functional areas within R&D, Manufacturing Operations, Engineering, Technical Services, and Supply Chain at multiple manufacturing sites, Commercial and others, to ensure that all needed activities are identified, integrated into a comprehensive plan, and executed within budget, scope and on time. Complex projects include suspensions, peptides, new therapeutic entities, high containment operations, third party projects and others as assigned.
Plan complex programs by integrating and linking the external partner (or R&D) and internal cross-functional (research and development, regulatory, manufacturing, quality, clinical and other), activities to meet required business and financial goals
- Drive activities being performed by the partner as well as the internal project team to complete on or ahead of schedule, while weighing risks to overall project and portfolio, and escalate issues as needed to the R&D and Business Development leadership teams
- Create realistic project timelines based on input from the partner and project team as well as the R&D and Business Development Leadership Teams
- Create a project budget that captures costs required to take the project from inception through to launch. The Sr. PM will be responsible for project budgets between $1M and $15M
- Manage between 15 and 20 active projects at various stages
- Direct project spend, resource activities, and capital expenditures
- Ensure project meeting minutes are accurately captured and issued in a timely manner
- Maintain an up to date risk register, to include mitigation strategies, costs to mitigate, and monitor secondary or residual risks as necessary
- Lead and direct 2-3 process improvement projects that benefit the PMO and/or R&D each year
- Minimum: Bachelor’s degree or equivalent in appropriate discipline.
- Desired: Master’s degree, PMP Certification or equivalent in related discipline.
- Minimum: 5-7 years of project management experience and 8-10 years of pharmaceutical product development, process development, business development, commercialization and/or equivalent experience.
- Desired: 7-9 years of project management experience and 10-12 years of pharmaceutical product development, process development, business development, commercialization and/or equivalent experience.
- Ability to lead teams within the organization and represent department initiatives.
- Proven ability to effectively influence and collaborate across multiple functional areas to drive projects effectively and provide guidance to project management team.
- Extensive knowledge of applicable laws and regulations regarding development and manufacturing of pharmaceuticals.
- Ability to process and make conclusions quickly.
- Ability to manage risk and be accountable for projects/personnel under supervision.
- Must have demonstrated ability to coach and mentor high level development personnel.