PDS Analytical Development & GMP Sr. Analyst

At Thermo Fisher Scientific, you'll tackle exciting work and join a team that values performance, quality, and innovation. As an integral part of our successful global organization, we encourage you to excel. With revenues exceeding $35 billion and the industry's largest R&D investment, we provide our employees with the resources and opportunities to make significant 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.
• Conduct laboratory investigations and prepare scientific documents, including methods, protocols, and reports.
• Maintain equipment and materials in good condition and manage 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).
• High proficiency in Empower 3.0 software for processing HPLC complex data.
• Experience in a cGMP environment and familiarity with stability and routine tests on APIs and finished products.
• 3+ years of laboratory experience, preferably in a pharmaceutical, biotechnology, healthcare, research, or academic environment.