PDS AD&GMP Technician
As the world leader in serving science, our work is more than something that fills our days – what we do has great purpose. Our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research to clinical to commercial production means you can have a broad and meaningful impact here at Thermo Fisher Scientific. All while working in an environment where you will be supported, valued and rewarded for your performance.
PDS AD&GMP Technician
Job Description
At Thermo Fisher Scientific, you'll begin exciting work and join a team that values performance, quality, and innovation. We encourage you to excel as an integral part of our successful global organization. With revenues exceeding $35 billion and the industry's largest R&D investment, we provide our employees with the resources and chances to create meaningful contributions.
Monza offers coordination with controlled drug regulations in Europe and the U.S. as well as disposable manufacturing technologies and fully coordinated secondary packaging services and has received regulatory approval from various international regulatory inspection agencies, including: ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, Turkey. The Monza site currently supplies over 20 countries – all the major international markets, including the U.S., Europe, and Asia Pacific.
The candidate will join the PDS Analytical Development & GMP Department in a newly built Pharmaceutical Department (PDS).
Responsibilities
- Perform sophisticated laboratory activities using analytical tools such as HPLC, GC, IR, UV-Spectrophotometer, supporting product development efforts and stability testing.
- Conduct testing of raw materials, in-process & finished products, formulations according to SOPs.
- Develop, transfer, and validate analytical methods, and compile data for documentation.
- Ensure all testing processes and documentation meet SOPs and cGMP standards.
- Maintain equipment and materials in good condition and handle waste according to company procedures.
Requirements
- Bachelor’s degree in chemical pharmaceutical, biology, chemistry, biotechnology, or a related field, or equivalent work experience and knowledge.
- Proficiency with MS Office suite.
- In-depth knowledge of base analytical techniques and more advanced instrumentation (HPLC, FT-IR, Capillary Electrophoresis).
- Knowledge of Empower 3.0 software for processing HPLC data is preferrable.
- Experience in a cGMP environment and familiarity with stability and routine tests on APIs and finished products.
- 1+ years of laboratory experience, preferably in a pharmaceutical, biotechnology, healthcare, research, or academic environment.
Languages
- Italian
- English
Personality Traits
- Flexibility
- Good organization and planning skills
- Strong listening and communication skills
- Ability to work collaboratively in a team
Work Schedule
Flex 12 hr shift/days
Environmental Conditions
Laboratory Setting
