Analytical Development Specialist

1 settimana fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

About Thermo Fisher Scientific

We are a leading global biotechnology company that values performance, quality, and innovation. With revenues of over $35 billion and the largest investment in R&D in the industry, we empower our employees to create significant contributions to the world.

Our Monza Site

Our Monza site is a state-of-the-art facility that offers compliance with controlled drug regulations in Europe and the Americas. We have received regulatory approval from various international regulatory inspection agencies, including ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, and Turkey. Our site currently supplies over 20 countries, including major international markets in Europe, Asia Pacific, and beyond.

Job Summary

We are seeking an Analytical Development Specialist to join our team in the Analytical Development & GMP Department. As a key member of our team, you will be responsible for testing raw materials, in-process and finished products, formulations, and ensuring all testing processes meet SOPs and cGMP regulatory standards.

Key Responsibilities

  • 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.
  • 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.

Language

  • English.

Personality Traits

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

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