Senior Analytical Specialist

5 giorni fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

As part of Thermo Fisher Scientific, you'll embark on challenging work, collaborating with a team that values performance, quality, and innovation. You'll be encouraged to excel in a successful, growing global organization with revenues exceeding $35 billion and the industry's largest investment in R&D, allowing you to make significant contributions to the world.

Monza offers compliance with controlled drug regulations in Europe and internationally, as well as disposable manufacturing technologies and fully coordinated secondary packaging services. Regulatory approval has been received from various international regulatory inspection agencies, including ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, and Turkey. The Monza site currently supplies over 20 countries, serving major international markets, including Europe and Asia Pacific.

In this role, you will join the Analytical Development & GMP Department in a new-built Pharmaceutical Department (PDS). You will utilize numerous analytical tools for small and large molecule analysis, such as HPLC, GC, IR, UV-Spectrophotometer, and other minor equipment. This work will support product development efforts (both API and Drug Product) along with Stability testing and other client-requested endeavors. This role requires experience in working in a cGMP environment and familiarity with using Empower software. MS Office experience is required.

Main Tasks

  • Responsible for testing of raw materials (especially API), in-process & finished product, formulations, and according to SOPs.
  • Analytical Method Development, Analytical Method Transfer and Validation, routine and stability analysis. Compiles data for documentation of test procedures, prepares reports. Ensures all testing processes, monitoring, and departmental documentation meet SOPs and cGMP regulatory standards.
  • Supplies to the development of new concepts, techniques, and standards. Involved with Assists in the preparation of CoAs.

Requirements:

  • Required: Bachelor's degree in chemical pharmaceutical, biology, chemistry, biotechnology, or related field or equivalent work experience and knowledge.
  • Office program.
  • In-depth knowledge of the most common analytical techniques and required instrumentation (HPLC, FT-IR, UV-VIS, Physical tests, etc.).
  • Stability and routine tests on APIs, finished products.
  • Knowledge of company procedures and GMPs.
  • Knowledge of notions and laboratory computer programs.
  • BS required/MS preferred in a science-related field and 1-2 years of laboratory experiences, preferably in a pharmaceutical, biotechnology, healthcare, research, or academic environment.

Languages:

  • English.

Personality traits:

  • Flexibility.
  • Good organization and planning skills.
  • Ability to work in a team.

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