Unternehmen
Hygiena Diagnostics GmbH
Über diese Stelle
Über Hygiena Diagnostics GmbH
You don't just want to fill a position at a large corporation – you want to actively improve processes and drive a team forward? With us, you can really make a difference!
We are a growing biotechnology company and have a clear mission: With our innovative real-time PCR kits and the development of ATP and immunological detection systems, we ensure greater safety in the food industry. Our comprehensive systems knowledge enables us not only to apply these technologies, but also to continuously develop them in-house. Our products have direct social relevance – and you can actively contribute to making them even more efficient and sustainable! While others are still sitting in endless meetings, we put new technologies directly into practice – with your input! We stand for a modern management culture, characterized by our own corporate values. Personal responsibility, team spirit and a positive attitude toward change are the key to our success.
WE ARE HIRING
GLOBAL SCIENTIFIC AFFAIRS MANAGERS (M/F/D)
LOCATION: POTSDAM (GERMANY) OR REMOTE
Aufgaben
- Develop and deploy global strategies for method certification and recognition for new product development, product improvement, modification, and scope extension
- Define method application scopes and study designs in accordance with standards, guidance documents, and applicable technical regulations
- Develop and ensure procedures for validation approvals to support and improve Hygiena’s Product Commercialization Process (PCP)
- Build and maintain relationships with regulatory authorities; act as liaison between Hygiena, regulatory agencies, and industry partners
- Provide scientific evidence and regulatory support to promote validation acceptance in national regulations and customer facilities
- Represent Hygiena in scientific committees, standardization working groups, and regulatory meetings; present at industry conferences; engage with AOAC International, ISO, and national committees
- Monitor regulatory trends, developments, and emerging scientific needs
Fähigkeiten
- Master’s or Ph.D. in Microbiology, Food Science, Analytical Sciences, Biotechnology, or related field
- Minimum 5 years of experience in scientific affairs, regulatory affairs, or method validation in the food safety, water microbiology, or analytical testing industries
- Deep knowledge of ISO 16140, AOAC validation studies, food safety and quality regulations
- Strong ability to translate complex scientific data
- Strong networking, stakeholder engagement, and relationship-building skills
- Exceptional written and verbal communication skills with a proven ability to engage technical audiences
- Demonstrated strategic thinking, analytical capabilities, and problem-solving skills
- Highly self-motivated and adaptable in a fast-paced, matrixed organization
- Excellent written and verbal English
- Able to travel up to 30%
Standort
Adresse
Potsdam, Remote, Deutschland