Manager Verification mfd - Research and Development

Work Schedule

Environmental Conditions

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science with annual revenue of approximately $40 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 increasing productivity in their laboratories improving patient health through diagnostics or the development and manufacture of lifechanging therapies we are here to support them. Our distributed team comprises more than 100000 colleagues offering an outstanding mix of groundbreaking technologies simplified purchasing and pharmaceutical solutions under our renowned brands like Thermo Scientific Applied Biosystems Invitrogen Fisher Scientific Unity Lab Services Patheon and PPD.

Location/Division Specific Information:

Phadia is the leading supplier of fully automatic blood analysis systems for allergy and autoimmune diseases. With our innovative products we set standards worldwide and assist clinicians in providing fast and reliable diagnoses thus helping patients at an early stage. Phadia GmbH in Freiburg is the German subsidiary of the Immunodiagnostics division of Thermo Fisher Scientific a global company that develops manufactures and distributes in vitro diagnostics in the field of allergy and autoimmune diagnostics. Our customers expect a consistently reliable and high standard of quality from our products which we ensure through innovative biochemical and medical technology solutions as well as highly qualified and motivated employees.

A Day in the Life:

As the Verification Manager (m/f/d) you will be pivotal in driving verification studies to ensure the performance of diagnostic assays in the autoimmunity space. Leading a skilled team of scientists and technicians your role will emphasize handson management of verification processes and technical guidance ensuring compliance with regulatory requirements. You will collaborate with internal teams to deliver highquality verification data within defined timelines playing a critical role in the product development lifecycle.

Responsibilities:

• Direct and lead the of verification studies for autoimmunity assays coordinating all aspects from planning to final reporting.
• Ensure all verification activities adhere to regulatory guidelines including IVDR and ISO13485 updating verification protocols and technical documentation accordingly.
• Coordinate the collection thorough analysis and accurate reporting of verification data upholding the highest standards of data integrity and accuracy.
• Provide handson technical support and mentorship to the verification team. Promote professional growth and skill development through personalized training plans and regular performance reviews.
• Work closely with R&D Quality and Regulatory Affairs departments to streamline verification processes and ensure flawless project .
• Update verification protocols and technical documentation in accordance with current regulatory standards.
• Handle project timelines and resource allocation effectively ensuring that verification studies are delivered on schedule and meet all project goals.
• Serve as the primary contact for both internal partners and external bodies such as notified bodies and regulatory agencies ensuring clear communication and compliance adherence.

Internal Partners:

R&D Production Planning Marketing QA/RA PMO MSA

External Partners:

Notified bodies Regulatory Agencies (as required for compliancerelated issues)

Minimum Requirements/Qualifications:

• Advanced degree (PhD preferred) in Biology Immunology or a related field.
• Profound experience in assay development or verification with significant leadership responsibilities in the IVD or diagnostics field.
• Demonstrated experience managing teams ideally of five or more members.
• Indepth knowledge of regulatory standards such as ISO13485 and IVDR.
• Strong interpersonal skills with a keen attention to detail and a confirmed ability to handle multiple initiatives simultaneously.
• Leadership skills with a strong record of mentoring and developing team members.
• Excellent social skills for effective partnership across functions.
• Fluency in English both written and spoken. German skills nice to have.
• Preferred Qualifications:
  • Direct experience with autoimmune diagnostic assays.
  • Proficiency in verification data analysis and reporting tools.

What we offer:

• Employment with a forwardthinking organization
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture which stands for integrity intensity involvement and innovation

If you are interested please apply online with your CV and Motivation Letter including possible start date and salary expectations.

At Thermo Fisher Scientific each one of our 100000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.

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.

Apply today!

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