PDS Analytical Development GMP Sr Analyst
PDS Analytical Development GMP Sr Analyst
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Work Schedule
7 1/2 hr shiftEnvironmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Laboratory Setting Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc. Will work with hazardous/toxic materialsJob Description
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 a newly built Pharmaceutical Department (PDS).
Responsibilities
Perform sophisticated laboratory activities using analytical tools such as HPLC GC IR UVSpectrophotometer supporting product development efforts and stability testing.
Conduct testing of raw materials inprocess & 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
Bachelors degree in chemical pharmaceutical biology chemistry biotechnology or a related field or equivalent work experience and knowledge.
Proficiency with MS Office suite.
Indepth knowledge of base analytical techniques and more advanced instrumentation (HPLC FTIR 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.
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.
Required Experience:
Director
Employment Type
Full-Time
