d) - Research and Development at Thermo Fisher Scientific

Freiburg, Baden-Wurttemberg, Germany

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Diagnostics, Biotechnology, Healthcare, Life SciencesIndustries

Requirements

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
In-depth knowledge of regulatory guidelines, including IVDR and ISO13485

Responsibilities

Advise and manage the execution of verification studies for autoimmunity assays, supervising all aspects from planning to final reporting
Ensure all verification activities closely 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 hands-on 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 seamless project execution
Update protocols and technical documentation in accordance with current regulatory standards
Manage 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 (R&D, Production Planning, Marketing, QA/RA, PMO, MSA) and external bodies (notified bodies, regulatory agencies), ensuring clear communication and compliance adherence

Skills

Verification Studies

Diagnostic Assays

Autoimmunity Diagnostics

Team Leadership

In Vitro Diagnostics

Biochemical Technology

Medical Technology

Assay Performance

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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