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Staff Pathlogist

Merck KGaA, Darmstadt, Germany

St. Louis, Missouri, United States

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.

That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Staff Pathologist Your Role: Working in collaboration with other members of the Pathology team, R&D colleagues, Operations, and Quality, the Staff Pathologist is a key contributor in driving Company product innovation, providing technical assessments of the clinical and technical literature, offering inputs to business cases, and generally supporting the development of histopathology products; scores and interprets stained tissue slides in support of current and new product development and contributes to experimental designs to meet required IVD outputs; participates in tradeshows and seminars, collaborates with industry key leaders, and provides clinical and technical mentoring to staff with respect to the applications of Company products; provides pathological expertise associated with the development of antibody products and reagents in compliance with quality and regulatory requirements.

Essential Functions: Provide expertise in the research, development, and production of Histopathology products Analyze and score tissue slides for Research and Development and product Quality assessments Assess tissue blocks for suitability in research, development, QC and commercial sale as assay control slides Contribute to the preparation of business cases for new products offerings Provide support for the launch of new products Interface with pathologists and histology professionals to understand specific needs and develop product and application solutions Serve as a technical consultant in support of the interpretation of stains and product applications Provide technical and clinical expertise in completing risk assessments and provide inputs into the risk management process Provide technical and clinical training for staff, customers, commercial partners, etc.

Assist in preparation of patent applications Contribute to the preparation of regulatory submissions, as needed, to obtain product licenses, clearances, and/or approvals required for marketing and distributing products (including IVDR performance evaluation and clinical evaluation documents) Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual Additional duties as assigned or required to support the business Minimum Qualifications: An advanced degree in pathology or a related discipline is strongly preferred A minimum of 5 years’ experience in the conduct and scoring of immunohistochemistry, in situ hybridization (i.e., FISH), and other histopathology stains is required Experience in risk assessments and the risk management process Experience in technical consulting Thorough knowledge of company testing services, technical principles and applications as they apply to your position.

Preferred Qualifications: Knowledge of immunohistochemistry and ability to grade immunohistochemistry slides required Knowledge of regulatory and standard requirements applicable to the site, i.e., MDSAP, ISO 13485, IVDR Proficiency in the use of microscope and other standard laboratory equipment Excellent oral and written communication skills Excellent organizational, time management, and project management skills Computer skills in Office 365 products Advanced presentation skills focused on training and/or teaching various audiences

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