Research and Development Program Manager - Biomatrica Inc.

Summary of Major Responsibilities:

The Program Manager successfully delivers solutions to support the organization’s vision and strategic direction. This role manages and leads large, high risk, high visibility, and critical projects for across the Organization. These projects are often highly complex and impact many users. This position ensures successful integration and communication between multiple projects. This is a hands-on role that requires close collaboration with all levels of Exact Sciences. 

 

This Program Manager will support the Research and Development enabling function within our complex IVD products and programs, which include systems, assays, reagents, instruments, and software. The position will manage the Next-Gen Sequencing (NGS) product development programs and ensure compliance with product development design controls. The Program Manager will partner with leads in Marketing, Clinical and Regulatory Affairs, Exact Sciences Laboratories, Technical Services, and Operations, among others to ensure cross-functional coordination and timely delivery of new products.

Essential Duties and Responsibilities:

• Lead and coach multiple efforts and teams to deliver work successfully.
• Apply project management methodologies and best practices.
• Work with business stakeholders to define strategy and requirements in order to define and execute a collection of projects across the business.
• Develop schedules, budgets, risk management plans, quality goals, and lead the team to success.
• Maintain detailed program metrics around initiative goals and communicate progress to key stakeholders.
• Drive positive change management via planning, communications, and relationship management.
• Make critical decisions based upon a combination of data analysis, experience, and judgement.
• Formulate, organize, and monitor inter-connected projects to include coordination of cross-project activities.
• Develop and mentor program and project team members.
• Listen, influence, negotiate, and mitigate conflict while building relationships achieving desired results.
• Partner with multiple internal cross-functional teams and successfully manage multiple projects simultaneously. 
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Regular and reliable attendance.
• Ability to work nights and/or weekends, as needed.
• Ability to work designated schedule.
• Ability to lift up to 10 pounds for approximately 5% of a typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability and means to travel between local Exact Sciences locations.
• Ability to travel up to 10% of working time away from work location, may include overnight/weekend travel.

Qualifications:

Minimum Qualifications

• Bachelor’s Degree in Business Administration, Engineering, Information Technology, Management Information Systems, or a related discipline.
• 8+ years project management experience with increasing responsibility of scope and leadership.
• 5+ years managing and leading large impact, large budget, high risk, client facing, and critical projects.
• 5+ years using Project Management software.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications:

• PMI certification.
• Master’s Degree.
• Advanced Degree (Masters or PhD).
• 5+ years project management experience with increasing responsibility of scope and leadership.
• 7+ years of relevant experience in life sciences, biotechnology, diagnostics, pharmaceutical, or medical device field.
• 3+ years managing design control process, compliant with ISO 13485 standards and 21 CFR 820 regulations.
• Proven ability to manage in vitro diagnostic and/or NGS product development process.
• Experience in projects that include integration of biological systems with automation and software applications.

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EEO Disclosure:

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.