Analytical Development & GMP Scientist (maternity cover)

at  Thermo Fisher Scientific

JOB DESCRIPTION

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $35 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.
Monza offers compliance with controlled drug regulations in Europe and the U.S. as well as disposable manufacturing technologies and fully integrated 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 Analytical Development&GMP Department in a new built of Pharmaceutical Department (PDS).
In this role you will use numerous analytical tools used for small and large molecule analysis, such as HPLC, GC, IR, UV- Spectrophotometer and other minor equipments. This work will be supporting product development efforts (both API and Drug Product) along with Stability testing and other endeavors requested by the client. This role will require experience in working in a cGMP environment. The candidate should be familiar 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.
• Contributes to the development of new concepts, techniques, and standards. Involved with Assists in the preparation of CoAs.
• Takes care of the kitting activities for the execution of the department analyzes on the basis of internal planning in accordance with the methods in use.

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

• 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.
• Contributes to the development of new concepts, techniques, and standards. Involved with Assists in the preparation of CoAs.
• Takes care of the kitting activities for the execution of the department analyzes on the basis of internal planning in accordance with the methods in use