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Wissenschaftlicher Mitarbeiter im Bereich F&E (m/w/d) - Job Opportunity at MEDICHEM Diagnostica GmbH

Steinenbronn, Germany
Full-time
Mid-level
Posted: April 21, 2025
Hybrid
EUR 55,000 - 75,000 annually based on location and role requirements in the German biotech sector

Benefits

Comprehensive pension plan with employer contributions, positioned above industry average
Flexible work arrangements including home office options, supporting work-life balance
Company bike program (Jobrad) promoting sustainable commuting and employee wellness
Health management program with subsidized fitness courses
Flexible working hours with self-organized scheduling capabilities
Professional development opportunities through project leadership

Key Responsibilities

Lead strategic development of reference materials for forensic, toxicological and clinical laboratory analytics
Direct project management of collaborative initiatives with research institutions and industry partners
Oversee quality control processes ensuring compliance with IVDR 2017/746 regulations
Drive technical documentation and knowledge transfer to production teams
Manage stakeholder communications across international partnerships
Develop and implement innovative analytical methodologies

Requirements

Education

Master's degree, Diploma, or PhD in Biology, Chemistry, Biochemistry, Pharmacy, Biotechnology, or Process Engineering

Required Skills

Advanced proficiency in MS Office and statistical software Fluent German and English communication skills Project management capabilities Analytical thinking Leadership and persuasion abilities Team collaboration Customer orientation Business acumen Strong organizational skills
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Sauge AI Market Intelligence

Industry Trends

The in-vitro diagnostics market is experiencing rapid growth driven by increasing demand for precise diagnostic tools and reference materials, particularly in forensic and toxicological applications Regulatory changes like IVDR 2017/746 are creating higher barriers to entry and increasing the importance of compliance expertise Growing emphasis on international collaboration in reference material development indicates a shift toward standardized global diagnostic protocols

Role Significance

Likely part of a specialized R&D team of 5-10 professionals, with direct collaboration with quality management and production teams
Mid to senior-level position with significant project ownership and strategic input capabilities

Key Projects

Development of new reference materials for emerging diagnostic needs International collaboration projects with research institutions Regulatory compliance initiatives for IVDR 2017/746 implementation Quality control system optimization and documentation

Success Factors

Ability to balance scientific expertise with project management skills Strong understanding of regulatory frameworks in diagnostic development Excellence in cross-cultural communication and stakeholder management Capacity to translate research outcomes into practical production processes

Market Demand

High demand with growing market need for specialists in regulatory compliance and reference material development

Important Skills

Critical Skills

Expertise in analytical method development and validation Project management skills with focus on international collaboration Regulatory compliance knowledge especially regarding IVDR 2017/746 Scientific communication skills in German and English

Beneficial Skills

Experience with quality management systems Understanding of production processes Knowledge of laboratory accreditation requirements Familiarity with forensic and toxicological analytics

Unique Aspects

Rare combination of scientific development work with international project management
Direct involvement in shaping diagnostic industry standards through collaboration with professional associations
Opportunity to influence global laboratory practices through reference material development

Career Growth

2-4 years in role before advancement opportunities, depending on project success and business growth

Potential Next Roles

R&D Director Technical Operations Manager Quality Assurance Manager Product Development Lead

Company Overview

MEDICHEM Diagnostica GmbH

MEDICHEM Diagnostica represents a specialized player in the in-vitro diagnostics sector with strong focus on reference materials and quality control products

Well-established regional leader with growing international presence in specialized diagnostic materials
Strong position in German market with expanding European footprint
Professional environment balancing scientific rigor with entrepreneurial flexibility, emphasizing individual responsibility and innovation
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