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 Program Management Office (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.
Responsibilities
- Program leader accountable for overall program execution and outcome
- Leadership of team accountable for development and commercial delivery of new product development initiatives; programs encompass the full product life cycle from concept assessment 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 cross-functional Program Core Team to ensure tight coordination on execution and delivery.
- Provide guidance on conformance of development activities to established 21 CFR Part 820-compliant Design Control procedures and Mercy Product Development Process.
- Hold team members accountable for areas of responsibility to the program team and ensure support of and focus on program objectives.
- Model servant leadership, commitment and collaboration to establish high performing, empowered and accountable team culture.
- 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.
Requirements
- 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 and in particular demonstrated success leading programs/teams through Feasibility/Early Development into later Development stages.
- Experience with projects focused on the development of Computational Biology/ Bioinformatics software and tools.
- Technical degree in science or engineering fields; preferably in Molecular Biology/Biochemistry
- 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 Program and Portfolio Management
Location: Prefer some on-site presence / hybrid schedule