Pds Analytical Development
3 giorni fa
Performs chemical and biochemical testing and assays in accordance to approved methods and SOP, recognizing and reporting in a timely manner out of specification results or deviations.
- Performs basic maintenance and troubleshooting of laboratory equipment
- Performs and assist in method validation as directed by AD Supervisor
- Assist in managing new projects and activities such as implementation of new lab instruments and procedures
- Assists in trouble shooting and investigations as required by AD Supervisor
- Performs preparation of reagents and standard substances, related controls according to SOPs / methods in use and deals with the kitting activities
- As a result of specific training, he takes care of the visual inspection of the products for the part in charge of the analytical laboratory (AQL) according to planning within the department.
- Prepare laboratory documentation (eg notebooks, registers, etc.).
**Requirements**:
- Good understanding of basic chemistry, chromatography, Gas Chromatography Immunoenzymatic techniques, biotech compound analysis and stability programs
- Experience in analytical development and methods validation in pharmaceutical (GMP/GLP) environment
- Good problem-solving skills and logical approach to solving scientific problems.
- Proficiency with the English language.
- Legibility in documentation as per Good Manufacturing Practices requirement.
- An awareness of regulatory requirements in the pharmaceutical industry (GMP/GLP and data integrity requirements), previous experience in pharmaceutical industry is strongly preferred
- Works well in a dynamic and result-driven team environment
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
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