d) - Research and Development at Thermo Fisher Scientific

Freiburg, Baden-Wurttemberg, Germany

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Diagnostics, Healthcare, BiotechnologyIndustries

Requirements

Master’s degree in biology, Immunology, or a related scientific field, preferably with additional qualifications or certifications relevant to the IVD industry
Profound experience in assay or medical device development, with a proven track record in managing product life cycles and compliance in a highly regulated environment
Strong leadership and problem-solving skills, excellent organizational abilities, and proficiency in managing complex projects and initiatives
Exceptional communication skills with fluency in English, both written and spoken

Responsibilities

CAPA Management: Lead the strategic oversight and execution of Corrective and Preventive Actions (CAPA) to resolve product-related issues, ensuring timely and compliant closure of CAPAs
Regulatory Compliance: Ensure all product care activities adhere to regulatory guidelines, including IVDR and ISO13485, maintaining up-to-date product documentation and compliance records
Cross-Functional Collaboration: Nurture strong relationships with R&D, Production Planning, Marketing, QA/RA, and other departments to effectively run CAPA and NC processes, ensuring seamless operational flow and adherence to regulatory standards
Continuous Improvement: Champion continuous improvement initiatives to enhance product quality and performance, applying root cause analysis to prevent recurrence of issues
Audit and Documentation Management: Prepare for and lead defense in internal and external audits; manage and be responsible for the creation and maintenance of all product care documentation to ensure full regulatory compliance
Team Leadership: Manage and develop a scientific team dedicated to product care activities, promoting professional growth and ensuring efficient and effective task completion

Skills

Product Management

Strategic Leadership

Regulatory Compliance

Quality Assurance

Market Analysis

Product Optimization

Autoimmunity Diagnostics

Allergy Diagnostics

In Vitro Diagnostics

Blood Analysis Systems

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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