Director/sr. Director Development

vor 4 Wochen

Mainz, Deutschland MAINZ BIOMED N.V. Vollzeit

Mainz Biomed is an international, innovative, and emerging biotechnology company. It specializes in the development of in vitro diagnostics in the field of cancer prevention and targets laboratories, physicians, companies, and patients with its portfolio.

To support our team, we are looking for a

**Director/Sr. Director Development (m/w/*)**

**for the development of in-vitro diagnostics
full-time (40 hours/week) for our Mainz location at the earliest possible date.

**Your responsibilities**:

- Management of several projects in product development from the idea to the finished product for the US market (incl. FDA approval)
- Planning and coordination of international projects and resources
- Responsibility for project-related expenditure budgets
- Interface between internal and external contacts in product development, quality management, production, sales, project and product management
- Management of a team of scientists and technical assistants
- Management of external development resources
- Implementation of SOPs, technical documentation and validation documents in accordance with international guidelines (CLSI guidelines)
- Development of real-time multiplex PCR tests for various questions Ensuring the transfer of manufacturing documents to contract manufacturers

**Your profile**:

- Completed diploma/ master's degree in biology/ biomedicine/ human genetics
- Doctorate in the above disciplines is an advantage
- At least 10 years of professional experience in the development of diagnostic test procedures, ideally professional experience in the field of multiplex PCR procedures
- At least 5 years of experience in molecular biology (esp. real-time PCR, assay design, DNA/RNA extraction, automation)
- Experience in stool-based diagnostics desirable
- At least 5 years of experience in project management
- Management experience, also in the coordination of external partners required
- Experience in quality management and the preparation of product-related documents, in particular under EN ISO 13485:2016
- Strong communication skills, ability to work in a team as well as personal responsibility and precision Excellent German and English (minimum C1) language skills, both written and spoken

**We offer**:

- A wide range of activities and plenty of opportunities to grow
- Attractive compensation including stock options
- The chance to contribute to an innovative and highly motivated team
- Permanent employment contract
- 30 days of vacation per year (full-time) Employer contributions to the company pension scheme

**Are you interested?

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