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 an experienced and motivated candidate to join our PMO team. This individual will be tasked with leading cross functional teams focused on development and commercialization of new products. Products may include diagnostic assays and computational biology software. In addition the Program Manager may lead select programs to support the organization’s strategic and operational imperatives. The position will be responsible for establishing scope, schedule, resource and budgets for programs, and for ensuring operational execution of program objectives across the functional matrix.
Candidates for this position must enjoy working for a fast-paced, cutting-edge company and demonstrate exemplary team leadership capabilities and a passion for contributing to our life-saving mission.
- Program leader accountable for overall program execution and outcome
- Leadership of team accountable for development and commercial delivery of new product development initiatives; encompasses full product life cycle from concept through feasibility and development to commercial launch and post market success.
- Program responsibilities may extend to leadership of other critical initiatives based on portfolio priorities and needs (e.g. process improvement programs, operational capabilities programs, etc.).
- Serve as Program Core Team Leader and primary liaison to the Program Governance team
- Lead the Core Team to ensure tight coordination on execution of cross-functional deliverables.
- Provide guidance on conformance of development activities to established 21 CFR Part 820-compliant Design Control procedures.
- Hold team members accountable for areas of responsibility to the program team and ensure support of and focus on program objectives.
- Drive concise and clear program updates to the Governance Team ensuring delivery of accurate and timely updates, and appropriate escalation and remediation of risks.
- Define and document Program scope, constraints and assumptions in detailed integrated program/project plans including schedule, resource needs and budget in accordance with the strategic goals and priorities of the organization.
- Establish and maintain a Program risk registry and lead teams to drive execution against risk mitigation plans as required to achieve Program objectives.
- Proactively implement and manage changes to the integrated program/project plans to ensure goals are achieved in a manner that is consistent with Mercy company values (The Mercy Way).
- Ensure program execution to appropriate standards of practice consistent with the Mercy Quality Management System and PMO policies and standards.
- Minimum 3 years of Program or Project Management experience
- 5+ years of experience with In Vitro Diagnostic, Medical Device or Life Sciences product development; strong preference for IVD project leadership experience.
- Technical degree in science or engineering fields; preferably in Molecular Biology/Biochemistry
- Experience with development of Computational Biology / Bioinformatics software.
- Strong working knowledge and experience with application of 21-CFR-Part 820 in product development, with emphasis on Design Controls and Risk Management.
- Experience leading cross-disciplinary development teams: R&D, Marketing, Quality, Operations, etc. to deliver new products to market.
- Expertise in Project Management software such as Microsoft Project; SmartSheet, Confluence; expertise in Microsoft applications including Word, Excel, and PowerPoint; working familiarity with requirements management software tools a plus.
- PMP certification preferred
Position: Program Manager / Sr. Project Manager
Hiring Manager: Vice President of Portfolio Management