PDS AD&GMP Scientist I

Whenyourepart of Thermo Fisher Scientificyoulldo challenging work and join a team that values performancequalityand innovation. As part of a successful growing globalorganizationyou 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 packagingservices andhas received regulatory approval from various international regulatory inspection agencies including: ANVISA JP PMDA US FDA EMA GCC States Canada Russia TaiwanTurkey. 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 is.

Responsible for testing of raw materials (especially API) in-process & finished productformulationsand 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 methodsSOPsand 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 programsdepartmentand client meetings and inmaintainingan orderly and safe laboratory environment.

Recognizes and solves analytical and product problems. Conducts anddocumentsinvestigations.Reviewslaboratory documentation for calculationentryand 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 toolsmaterialsand 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: Bachelors 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 andinstrumentation (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

At Thermo Fisher Scientific each one of our 80000 extraordinary mindshasa unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthiercleanerand safer.