Manager Verification (m/f/d) - Research and Development

ThermoFisher Scientific Manager Verification (m/f/d) – Research and Development in Freiburg, Germany

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office

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 life-changing therapies, we are here to support them.

Location/Division Specific Information: Phadia is the leading supplier of fully automatic blood analysis systems for allergy and auto-immune 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.

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 hands-on management of verification processes and technical guidance, ensuring compliance with regulatory requirements. You will collaborate with internal teams to deliver high-quality verification data within defined timelines.

Responsibilities:

1. Direct and lead the execution of verification studies for autoimmunity assays, coordinating all aspects from planning to final reporting.
2. Ensure all verification activities adhere to regulatory guidelines, including IVDR and ISO13485, updating verification protocols and technical documentation accordingly.
3. Coordinate the collection, thorough analysis, and accurate reporting of verification data, upholding the highest standards of data integrity and accuracy.
4. Provide hands-on technical support and mentorship to the verification team, promoting professional growth and skill development through personalized training plans and regular performance reviews.
5. Work closely with R&D, Quality, and Regulatory Affairs departments to streamline verification processes and ensure flawless project execution.
6. Update verification protocols and technical documentation in accordance with current regulatory standards.
7. Handle project timelines and resource allocation effectively, ensuring that verification studies are delivered on schedule and meet all project goals.
8. 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 compliance-related issues)

Minimum Requirements/Qualifications:

1. Advanced degree (PhD preferred) in Biology, Immunology, or a related field.
2. Profound experience in assay development or verification, with significant leadership responsibilities in the IVD or diagnostics field.
3. Demonstrated experience managing teams, ideally of five or more members.
4. In-depth knowledge of regulatory standards such as ISO13485 and IVDR.
5. Strong interpersonal skills, with a keen attention to detail and a confirmed ability to handle multiple initiatives simultaneously.
6. Leadership skills with a strong record of mentoring and developing team members.
7. Excellent social skills for effective partnership across functions.
8. Fluency in English, both written and spoken. German skills nice to have.

Preferred Qualifications:

1. Direct experience with autoimmune diagnostic assays.
2. Proficiency in verification data analysis and reporting tools.

What we offer:

1. Employment with a forward-thinking organization.
2. Outstanding career and development prospects.
3. Company pension scheme and other fringe benefits.
4. 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 100,000 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.

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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