PDS AD&GMP Senior Analyst

At Thermo Fisher Scientific youll 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 industrys 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 the 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.

• 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.

• Provide support with autonomy in the review of simpler analyses performed by other analysts.

Requirements

• Bachelors 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.

• Willingness to work two shifts (07:0013:15 / 13:2020:50)

Languages

• Italian

• English

Personality Traits

• Flexibility

• Good organization and planning skills

• Strong listening and communication skills

• Ability to work collaboratively in a team

In our company each one of our 80000 outstanding individuals has an exceptional story to share. Join us and contribute to our remarkable missionempowering our customers to create a healthier cleaner and safer world.