Mercy BioAnalytics, Inc. is a pre-commercial biotechnology company committed to reducing suffering and saving lives through the early detection of cancer. We are looking for a passionate individual to join our mission leading Portfolio Management for product development and process improvements programs across the organization.
This individual will lead the Portfolio Management Office for Mercy. Responsibilities will broadly include leadership for Program and Portfolio Management, including product and service development and process improvement initiatives. The successful candidate will apply leadership skills, cross-functional influence, and domain expertise to enable full commercial realization in alignment with business strategy and organizational goals. The candidate is expected to have a thorough understanding of Program and Portfolio Management best practices, including Design Control. It is important that the candidate works well in teams and exhibits exceptional situational leadership.
Candidates for this position must enjoy working for a fast-paced, cutting-edge company and demonstrate exemplary situational leadership capabilities and a passion for contributing to our life-saving mission.
- Lead and develop Program Management team members.
- Serve as the primary liaison to the executive team on Programs and Portfolio, including quarterly Portfolio Reviews
- Serve as primary sponsor of the company’s Product Development Process, consistent with Design Control best practices; ensuring appropriate documentation, training, and practice across Program Core Teams.
- Serve, as needed, as the Program Core Team Lead on key Programs of high visibility, complexity, or strategic importance for the company, managing definition and execution of Program scope, schedule and resources.
- Accountable for establishing and maintaining a balanced product development pipeline, contextualized for risk, business opportunity, and timelines.
- Responsible for ensuring resource allocation across programs and functions is consistent with portfolio priorities, escalating issues or risks as appropriate.
- Serve as a critical business partner to the head of Quality Assurance in the implementation and continuous improvement of Mercy’s Quality Management System.
- Sponsor continuous evolution and improvement of tools and infrastructure to support portfolio management and resource allocation.
- Advanced Degree in a relevant discipline; MBA or Masters/PhD in the life sciences
- 15+ years of experience in Life Sciences, Biotechnology, or Diagnostics industry; 10+ years leading Program and Portfolio management
- Proven track record for leading the Program & Portfolio Management function in the development and commercial launch of innovative products under design control
- Experience in both RUO and regulated product and service development; experience with regulatory submissions, including support for interactive Agency review strongly preferred
- Experience in advanced technologies and product development, with domain expertise in clinical immunoassay development strongly preferred
- Effective communication, collaboration and negotiation abilites; excellent written and verbal communication skills
- Ability to manage multiple large, strategic projects and effectively triage priorities in alignment with corporate goals
- Ability to work effectively and efficiently in a fast-paced and dynamic environment
- Proven leadership skills, both in direct management and matrix influence capacities
- Demonstrated ability to perform long-term project planning, team building and budgeting, applying operational excellence principles
- Strong working knowledge and application of relevant quality and regulatory standards (ISO, CLIA, QSR, IVDR) and track record of successful customer audits and quality inspections
- Expertise in Microsoft applications including Word, Excel, and Powerpoint; expertise in Project Management software such as MS Project; working familiarity with Atlassian suite (JIRA/Confluence) a plus
- Experience working with document control systems
- <5% travel