Summary of Major Responsibilities
The Senior Project Manager R&D manages a portfolio of complex, cross-functional in vitro diagnostic device projects ensuring business objectives are met and accomplished on time, within budget. This will include partnering with functional area leaders who are executing projects to ensure teams are able to deliver on the business’s needs. Acts as a change agent to drive adoption of project management best practices for the product development process.
Essential Duties and Responsibilities
- Lead pipeline project teams and design change project teams to accomplish project goals.
- Coaches and mentors functional area managers and project managers in product development processes and best practices.
- Troubleshoot problems associated with coordination, development, or design of projects. Escalate issues when critical risks arise and maintains pulse with project activities to ensure progress.
- Consult with functional area leaders, and review project proposals to determine goals, time frame, funding limitations, and procedures for accomplishing project, staffing requirements, and allotment of resources.
- Identify and schedule project deliverables, milestones and required tasks, dependencies, risks and opportunities associated with meeting the company’s priorities.
- Collaborate with assay and systems R&D teams responsible for the design and development of clinical diagnostic products to meet product design goals while maintaining compliance with the Quality System Requirements.
- Partner with cross functional leads in Marketing, Clinical and Regulatory Affairs, and Operations, among others, to ensure appropriate understanding and documentation of product requirements and timely delivery of products.
- Prepare status reports and modify schedules and plans as required.
- Keep management, team, and business areas informed of project status and related issues.
- Create MS Project schedules, and utilize the schedules to communicate and manage the work.
- Manage project budgets.
- Ensure that all required project management deliverables are created and accurate.
- Prepare projects for governance gate approvals.
- Able to organize, present, and convey complex problems or issues within and across other functions.
- Experience in a biotech-manufacturing environment, GMP and/or ISO.
- Exceptional verbal and written communication skills.
- Excellent attention to detail and organizational skills.
- Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
- Ability to frequently and accurately communicate with employees, customers, and vendors in person, via the telephone or by email.
- Constant walking or motion to coordinate work and interact with co-workers.
- Regular and reliable attendance.
- Support and comply with the company’s Quality Management System policies and procedures.
- Bachelor's degree in Molecular Biology, Biochemistry, Engineering, or related discipline.
- 5+ years of technical project management experience in the biotechnology field.
- 3+ years managing design control process, compliant with ISO 13485 standards and 21 CFR 820 regulations.
- Authorization to work in the United States without sponsorship.
- Proven ability to manage in vitro diagnostic product development process.
- Demonstrated ability to balance cost, quality and schedule constraints while escalating issues as needed. Demonstrated ability to prioritize and balance multiple competing priorities within and across multiple projects at the same time.
- Demonstrated success with oral and written communications/presentations, influence and persuasion, results orientation, facilitation, and teamwork skills.
- Experience working in a matrix management organization with primary responsibility for project success while relying on a team of resources which are not direct reports.
- Moderate to advanced proficiency with MS Project as well as MS Visio, Excel and PowerPoint.
- Experience in projects that include integration of biological systems with automation and software applications.
- PMI Project Management certification.
- Strategic planning experience.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.