Associate Director/ Sr Manager, Project Management - In Vitro Diagnostics
We are looking for an experienced Project Management leader. The successful candidate will be responsible for managing a complex development project and work closely with the project team members representing Assay Development, Engineering, Operations, Systems Integration, Quality and Regulatory. Must work effectively in a matrix team environment to develop integrated project plans, pro-actively manage and track key project deliverables. Provide regular project team deliverables and progress updates to Senior Management.
This position will report to the SVP, R & D.
Duties and Responsibilities:
- Proactively facilitate and lead team discussions on project strategies, short-term and long-term project planning, opportunities for expediting timelines, identification resource constraints, and proactively identify complex project issues and risks, and assure appropriate escalation.
- Manage Cross-Functional Project Team meetings and facilitate discussions using meeting management best practices to drive project strategy, scenario planning, cross-functional communication, timely and effective decision-making, and successful execution of program objectives. Develop agendas and summarize key meeting discussions and decisions.
- Manage timeline and integrated project development timelines for a complex platform including consumables, reagents, assay software and instrumentation.
- Develop, track and maintain project development timelines (integrated project plans), project deliverables and milestones; including understanding and communicating inter-dependencies and critical path activities.
- Work closely with and build strong working relationships with cross-functional team members to develop a collaborative team environment.
- Assist in the review of project team regulatory documents and SOP revisions, as needed.
- Identify enhancements and development of team processes, structures, and project reporting tools.
- May participate in audits by external certification organizations or regulatory agencies.
Position Requirements and Experience:
- BS in a scientific field required preferably in the biological sciences or chemistry, or in engineering or the physical sciences. MS degree highly desired.
- Experience with an excellent track record Project Management record for regulated products for IVD testing, including through product launch and post-launch support. Our ideal candidate will have both large and small company experience.
- Minimum of 8 years of related project management experience. PMP a plus.
- Outstanding communication, planning and organizational skills.
- Highly collaborative team player who fosters open communication and able to facilitate urgent needs and ability to positively influence others.
- Proficiency related to all elements comprising a typical phase-gate process for the development and launch of commercial products.
- Experience with projects employing Agile/Scrum methodologies.
- Experience with risk management for regulated products in the Medtech sector.
- Proven ability to analyze complex activities and information to help guide decision-making that meets the overall objectives and long-range plans of projects and the organization
- Excellent skills to proactively predict issues and solve problems, identify risks.
- Demonstrated success in decision-making within a multi-disciplinary, matrix team.
- Proven record of balancing strategic needs of the program with tactical day-to-day activities.
- Successful track record of creating and managing accurate integrated project plans/timelines and the use of project software (Smartsheet -a cloud-based project management scheduling tool, Visio, PowerPoint and Excel, etc.).
- This is an individual contributor role requiring finesse and a strong set of technical and people skills to influence, impact and lead the project management process for a dynamic and fast growing company in leading edge work. Opportunities to grow the project management function for high performing, successful individuals!