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. 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. 
 
As one of the largest biotechnology companies in Germany, we research, develop and produce innovative biomarker diagnostics and distribute our products in more than 65 countries. B•R•A•H•M•S is based in Hennigsdorf near Berlin, which is home to about 285 of the company’s 550 employees worldwide.
 
For our R&D PMO team we are looking for you as our new

Project Manager (m/f/d) – IVDR for CDD Biomarkers

Region Hennigsdorf/Berlin
 
This position is responsible for leading the implementation of the new European IVD regulation for the B.R.A.H.M.S. Biomarker Business Unit of Thermo Fisher Scientific‘s Clinical Diagnostics Division, at a later point leading new product development teams. It requires significant cross-functional coordination and leadership, excellent written and communication skills, and the ability to drive collaboration and decision making with all key stakeholders. The ideal candidate will have strong Project Management skills, be interested to work internationally, able to understand business strategy, regulation and quality systems, diagnostic technology and clinical applications, able to focus at a detailed level and being comfortable interacting with senior executives and project team members alike. We need a passionate Project Manager who will deliver execution excellence, making optimal use of the Thermo Fisher Scientific Phase Gate and other processes. Come help the Thermo Fisher Scientific team deliver world-class products and solutions to our customers to make the world healthier.
 
A Project Manager’s role at Thermo Fisher Scientific / CDD Biomarkers means

• To manage higher complexity, cross-functional initiatives such as the implementation of IVD R and new product development.
• Representing and leading project teams at our two locations in Hennigsdorf, Germany and Nimes, France through the Phase gate process, managing scope, schedule, risks, issues, trade-offs, decision making, communications, and expectations. 

Your Qualification

• Bachelor’s degree (B.S./B.A.) minimum, preferably in a scientific/technical discipline (e.g. biology, chemistry, engineering).
• Minimum of 4 years of experience combined between project management and product development, preferably in the life sciences or health care industries.
• PMP certification preferred.
• Familiarity with In Vitro Diagnostics, Design Control Quality Systems and Immunoassays is a plus.
• Excellent interpersonal and relationship building skills
• Excellent leadership skills and the ability to influence stakeholders in other functions over whom the Project Manager has no direct managing authority.
• Excellent oral and written English communication skills.

We offer

• Employment with an innovative, future-oriented, international organization.
• Exciting company culture which stands for integrity, intensity, involvement and innovation.
• Outstanding career and development prospects.
• Company pension scheme.

 
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission.
 
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, disability or any other legally protected status.