Senior Program Manager

About This Role

The Senior Program Manager leads complex sustaining programs and projects for the reagents platform, ensuring business continuity, product reliability, quality improvements, and cost optimization. This role involves managing cross-functional and multi-site teams, advocating for program priorities, and securing stakeholder commitment to drive critical initiatives in a regulated environment.

Responsibilities

• Lead complex sustaining programs and projects for the reagents platform, ensuring business continuity and long-term product reliability.
• Drive initiatives focused on quality improvements, product enhancements, and cost optimization to maintain competitiveness and compliance.
• Facilitate decision-making for projects with multiple dependencies, balancing technical, operational, and business priorities.
• Manage cross-functional and multi-site teams, ensuring alignment and collaboration across R&D, manufacturing, quality, and regulatory functions.
• Define program priorities and resource needs, negotiating resourcing plans to meet timelines and deliverables.
• Influence stakeholders at all levels to secure commitment and resolve challenges impacting sustaining activities.
• Lead planning and execution for sustaining projects, ensuring clarity of requirements, schedules, and adherence to quality and regulatory standards.
• Own adherence to budgets, timelines, and performance metrics for projects aimed at improving reliability and reducing costs.
• Mentor and guide program managers and team leads, fostering collaboration and continuous improvement.
• Drive risk management strategies and lead cross-functional problem-solving to mitigate risks impacting product availability or compliance.

Requirements

• 8+ years of experience managing complex projects and programs within the Biotech/IVD or Medical Device industry
• Proven track record of leading large-scale, multi-site programs in a matrixed organization
• Expert-level decision-making ability and negotiation skills
• Strong understanding of Biotech/IVD or Medical Device product development and global regulatory registration processes
• Solid knowledge of product lifecycle management (PLM) in regulated environments
• Proficiency with MS Project, Power BI, Excel, PowerPoint, and Teams

Qualifications

• Bachelor of Science (BS) degree in a science or engineering field
• 8+ years of progressive experience managing complex projects and programs within the Biotech/IVD or Medical Device industry, including reagent-related platforms.

Nice to Have

• Master’s degree or equivalent in science, engineering, or business
• Deep knowledge of IVD Medical Device Regulations, Biotech Product Development Process, and Operations
• Experience with reagent manufacturing or sustaining activities in a regulated environment
• Experience with SAP and enterprise resource planning systems

Skills

* Required skills

Benefits

Certifications