Staff Program Manager - IVD
About the Job
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Location/Division Specific Information:
- Carlsbad, CA., South San Francisco, CA. OR Austin, TX.
- Clinical Next-Generation Sequencing Division
How will you make an impact?
As Staff program manager you will manage development and regulatory submission of an In vitro diagnostic instrument system and Companion Diagnostic assay within the Clinical Sequencing Division. You will execute on project timelines and overall program goals from initial concept through successful commercialization and project closure. You will also identify and resolve, or escalate resource conflicts and gaps. This position reports to Director, Program Management Office.
What will you do?
- Lead matrixed team to ensure on time development and regulatory submission of a Next Generation Sequencing based In vitro diagnostic instrument system and Companion Diagnostic assay
- Conduct team meetings: Ensure decisions made, generate minutes, monitor progress and action items, to support successful project execution.
- Develop, monitor and control timeline for complex multiyear effort with exquisite detail
- Develop, monitor and control budget including resources and costs, including coordination with Finance and functional departments.
- Proactively identify risks and challenges: develop plans to address, facilitate tradeoff decisions, escalate to key internal stakeholders, removing obstacles.
- Ensure compliance to company quality management systems, policies and procedures for a regulated product
- Communicate weekly with Sr. leadership on status: changes in timeline, cost and risks
- Act with sense of urgency to drive issues to resolution in a matrixed environment and at various levels of management
- Adapts program to meet evolving business needs (e.g. business development requirements)
- Any other reasonable activity required by management/leadership
How will you get here?
- BS in Molecular Biology, Genetics or Engineering
- 4-6 years project management experience including principles, tools and applications. (i.e. timeline management, resource allocation, cost estimation, risks analysis).
- Experience with regulated products developed under 21 CFR Part 820 Subpart C - Design Controls (or other regulated therapeutic product development – such as drugs or biologics)
- Proficiency with Project Management software to manage complex project timelines and resources
- Proficiency with other Microsoft Office applications (Word, PowerPoint, Excel).
Required Competencies / Abilities:
- Exceptional written and verbal communication skills: assertively and effectively articulates complex concepts and ideas to broad audiences.
- Confidence interacting with various levels of management stays focused and on-point, able to raise problems or challenges in productive manner.
- Strong presentation skills: effective summarizing and presenting decision points and key considerations.
- Strong influencing skills: gets things done without formal authority.
- Strong negotiation skills: drives discussions and decisions toward desired results
- Strong interpersonal skills: cultivates relationships with key internal partners, manages conflict
- Outstanding orientation to teamwork: works collaboratively, effectively and efficiently with others
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.