Technical Project Manager (Analytical Validation Specialist)

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Global Professional Services is seeking an energetic, engaged and creative professional with experience in molecular platforms with an emphasis on qPCR. In this position you will be responsible for project management and execution of customer-facing projects, as well as development of value-added services on molecular biology platforms in regulated (e.g. clinical and pharmaceutical) and non-regulated markets. You will also co-lead and develop value-added professional services for the organizations instrument platforms in collaboration with product managers and other key global field-based personnel. Efficiency, accuracy, a keen willingness to learn, and the ability to work effectively with multiple stakeholders in a multi-cultural and geographically distributed environment are essential to success in this job.

Responsibilities:

• Interact with external stakeholders at all levels including laboratory scientists, laboratory technicians, laboratory directors, IT, QA as well as regulatory staff and/or consultants globally.
• Marshal internal resources including field service engineers, field application scientists, remote technical support personnel, technical sales specialists, product management, manufacturing and R&D scientists.
• Identify opportunities in laboratory workflows where the company can offer value-added services to speed production deployment of platforms, increase customer retention and prohibit competitive entry.
• Develop and pilot value-added services at customer sites and support commercialization of services.
• Work effectively in a structured product and service development process.
• Work effectively in an FDA regulated and/or ISO compliant environment.
• Identify areas for process improvement in the development, training and delivery of services.
• Additional and incidental work related to the primary duties may be required for company business needs from time to time.
• Manage the laboratory testing for the support of new service products and custom engagements.

• Project manages customer-facing engagements, on-site and off-site, to ensure timely execution and customer success.
• Execute customer-facing engagements and marshal internal resources including field engineers, field application scientists, remote technical support personnel, technical sales specialists, product management, manufacturing and R&D scientists
• Assist in the development of instrument qualification protocols (IQ/OQ) based on capabilities and applications of instrument platforms as well as US and international regulatory requirements including GxP, CLIA, IVD and the requirements of ISO and other standards bodies.

• Bachelor's or Master's Degree in a scientific discipline.
• 4+ years of molecular biology laboratory experience with an emphasis on NGS and real-time PCR in a clinical setting.
• Proven experience leading projects.
• In-depth knowledge and experience with techniques, applications and data analysis of NGS, , Sanger sequencing and real-time PCR.
• Customer-facing support and troubleshooting experience with real-time PCR platforms.
• Strong abilities in Microsoft Office (especially Excel).
• Excellent communication (verbal and written), negotiation, presentation, and interpersonal skills.

• Experience working with R&D on product development.
• Knowledge of and experience with current CLIA/CAP/New York State regulations.
• Experience with method validation on molecular biology platforms.
• Working knowledge of statistical methods.

At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today