Staff Program Manager, NGS CDx - Remote an option! at Thermo Fisher Scientific (San Diego, CA)

| San Diego, CA
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Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 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, South San Francisco, CA, - OR - Remote for ideal candidate
  • Clinical Next-Generation Sequencing Division

How will you make an impact?
As Staff Program Manager you will manage development and regulatory submission of Next Generation Sequencing based Oncology Companion Diagnostic (CDx) assays within the Clinical Sequencing Division. You will execute on project timelines and goals from initial concept through successful commercialization and project closure in coordination with external clients. 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 Companion Diagnostic assays with external clients.
  • Conduct team meetings: Ensure decisions are made, generate minutes, monitor progress and action items to support successful project execution.
  • Develop, monitor and control project timeline in conjunction with both internal functions and external clients.
  • Develop, monitor and control budget including resources and costs and in 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.
  • Act with sense of urgency to drive issues to resolution in a matrixed environment and at various levels of management.
  • Any other reasonable activity required by management/leadership.
How will you get here?
  • BS in Molecular Biology, Genetics or Engineering
  • At least 3 years project management experience including principles, tools and applications. (i.e. timeline management, resource allocation, cost estimation, risks analysis).
  • Experience with regulated medical devices developed under 21 CFR Part 820 Subpart C - Design Controls (or other regulated 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).
Knowledge, Skills, Abilities:
  • Exceptional written and verbal communication skills: assertively and effectively articulates complex concepts and ideas to broad audiences.
  • Experience working as a vendor for external clients highly preferred.
  • Confidence interacting with various levels of management stays focused and on-point, able to raise problems or challenges in productive manner.
  • Financial acumen: plans and oversees project budgets (Profit & Loss)
  • 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 90,000 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

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.
More Information on Thermo Fisher Scientific
Thermo Fisher Scientific operates in the Biotech industry. The company is located in Waltham, MA. Thermo Fisher Scientific was founded in 2022. It has 61393 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 497 open jobs at Thermo Fisher Scientific, click here.
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