Industrial Chemist - Biomedical Manufacturing

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7843tm

Our company, an innovative MedTech startup focused on the development of implantable devices for tissue regeneration, is looking for a:
**Industrial Chemist - Biomedical Manufacturing** The role supports process development, validation, and scale-up for the manufacturing of closely with the Engineering team to validate current production processes and support the development of new ones for the next industrialization phase. **Responsibilities** a. Develop, optimize, and scale chemical processes for manufacturing in accordance with ISO 13485 and FDA 21 CFR Part 820;
b. Perform validation activities (IQ/OQ/PQ) and prepare the related protocols and reports;
c. Support technology transfer from R&D; to Manufacturing, collaborating with Quality, Engineering, and Production teams;
d. Conduct risk assessments and root cause investigations for deviations or process issues;
e. Evaluate and qualify raw materials, chemicals, and suppliers to support process scale-up;
f. Implement and monitor process controls, including statistical process control (SPC) tools;
g. Contribute to continuous improvement activities to increase process efficiency and product quality;
h.



Draft and revise documentation such as procedures and technical reports related to the production process. **Requirements**:
1. Bachelor’s or Master’s degree in Industrial Chemistry, Chemical Engineering, or a related scientific field;
2. At least 5 years of experience in a GMP-regulated environment, with a minimum of 2 years in medical device manufacturing;
3. Hands-on experience with process development, scale-up, and validation of chemical processes;
4. Proficiency with analytical techniques such as HPLC, FTIR, UV-Vis, and Karl Fischer;
5. Knowledge of ISO 13485, FDA QSR, and related regulatory frameworks;
6. Familiarity with cleanroom operations and willingness to work in controlled environments when required;
7. Good command of spoken and written English;
8. Good knowledge of Microsoft Office tools. **Preferred**
- Experience with Lean Manufacturing or Six Sigma methodologies;
- Project management skills are considered a plus. **Work location**: Milan, Italy **Job Types**: Full-time, Permanent Pay: €40,000.00 - €55,000.00 per month **Education**: - Bachelor's (required) **Experience**: - Industrial Chemist - Biomedical Manufacturing: 5 years (required)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7843tm