Whenyou’repart of Thermo Fisher Scientific,you’lldo challenging work, and join a team that values performance,qualityand innovation. As part of a successful,growing global organizationyou 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.,Europeand Asia Pacific.

The candidate will join the PDS AnalyticalDevelopment&GMPDepartment in a newbuiltofPharmaceutical Department (PDS).

Depending on the indications received from the Team Leader, he carries out the tasks and activities listed below for which he has been enabled by theappropriate training, in compliance with company and departmental SOPs and current safety regulations

The analytical Scientist should be experienced in the use ofnumerousanalytical tools used for small and large molecule analysis, such as HPLC, GC, IR, UV- Spectrophotometer and other minorequipments 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 acGMPenvironment. The candidate should be familiar with using Empower software. MS Office experience isrequired

Responsible for testing of raw materials (especially API), in-process & finished product,formulationsand according to SOPs. He takescare activitiesas 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 ofCoAs

Documents all experimental datain accordance withAttributable, Legible, Contemporaneous, Original and Accurate (ALCOA). Independently carries out analysis usingequipmentas HPLC and UPLC, FT-IR, UV-Spectrophotometer, Viscosimeter following established procedures Analytical Methods & Standard Operating Procedures (SOPs).Works Proficiencywith Empower, MS Word & Excel Software. Performs basic troubleshooting to overcome system suitability failures. Recognizes and reports unexpected or OutOfSpecification (OOS) resultsimmediatelyto the Supervisor and conducts laboratory investigations under direction. Independently prepares raw data packages (notebook copies and Empower reports) for clients.

You will be shadowing and/orassistingin the preparation of scientific documents such as methods, protocols, reports, method development summaries, analytical methods,SOPsand other similar documentation.

Coordinate a group of analysts who conduct tests related to Analytical Method Development/Transfer/Validation, in-process samples, finished products, and stability samples. Interacts with internal and external clients to set timelines, understand work requests, define and resolve issues, assign and distribute work, and communicate results. Participates and contributes to safety programs,departmentand client meetings, and inmaintainingan orderly and safe laboratory environment.

Recognizes and solves analytical and product problems. Conducts anddocumentsinvestigations.Reviewslaboratory documentation for calculation,entryand GMP compliance.Solvescomplex, non-routine analytical and product problems independently. Oversees the documentation of laboratory experimentation in protocols and technical reports.

Takescare of the kitting activities for the execution of the department analyzeson the basis ofinternal planningin accordance withthe methods in use.

Takescare of keeping the materials in good condition for their use in the analytical field, guaranteeing their conservation under the conditionsindicatedin the corresponding documentation.

Collaborates in the evaluation of the materials to bepurchasedfor the assigned analytical activity and related documentation and, ifdesignated, takes care of the preparation of the corresponding purchase request.

Takes care of the tools,materialsand work environment, promptly communicating any anomalies to the Team Leader

In compliance with company procedures, it takes care of collecting waste and laboratory waste appropriately.

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 andrequiredinstrumentation (HPLC, FT-IR, UV-VIS, Physicaltestsetc..)

• Stability and routine tests on APIs, finished products

• Experience in Analytical Method Development/Transfer and Validation

• Knowledge of company procedures and GMPs

• Knowledge of notions and laboratory computer programs

• BS required/MS preferred in a science related field and 2-3 years of laboratory experiences, preferably in a pharmaceutical, biotechnology, healthcare, research, or academic environment

Languages

• English

Personalitytraits:

• Flexibility

• Goodorganizationand planning skills

• Listeningandcommunicationskills

• Ability to work in a team

AtThermoFisher Scientific, each one of our 80,000 extraordinary mindshasa unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier,cleanerand safer.