Lavori attuali relativi a Pds Analytical Development - Monza - Thermo Fisher Scientific


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    Monza, Italia Thermo Fisher Scientific A tempo pieno

    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 $40 billion and the largest investment in R&D in the industry, we give our...

Pds Analytical Development

3 mesi fa


Monza, Italia Thermo Fisher Scientific A tempo pieno

Work Schedule Other Environmental Conditions Office 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 RD in the industry, we give our people the resources and chances to create significant contributions to the world.
The candidate will join the PDS Analytical Development GMP Department in a new built of Pharmaceutical Department (PDS).
Depending on the indications received from Supervisor, he carries out the tasks and activities listed below for which he has been enabled by the appropriate training, in compliance with company and departmental SOPs and current safety regulations.
The Team Leader has the main responsibility to organize and plan laboratory activities in accordance with GMP, SOPs, ICH and Client's expectations.
They support PDS projects participating in daily calls with Clients and/or internal meetings in order to guarantee timelines fixed for projects.
They should be experienced in the use and troubleshooting of numerous analytical tools used for small and large molecule analysis, such as HPLC, GC, IR, UV-Spectrophotometer and other minor equipment.
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.
Responsible for coordinating and planning testing of raw materials (especially API), in-process finished product and formulations according to SOPs.
Takes care of activities such as Analytical Method Development, Analytical Method Transfer and Validation, routine and stability analysis.
Verifies data for documentation of test procedures and 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.
Verifies that all experimental data are in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).
Independently assures the compliance of analysis using equipment such as HPLC and UPLC, FT-IR, UV-Spectrophotometer, Viscosimeter following established procedures, Analytical Methods Standard Operating Procedures (SOPs).
Performs sophisticated troubleshooting to overcome system suitability failures.
Recognizes and reports unexpected or Out Of Specification (OOS) results immediately to the Supervisor and conducts laboratory investigations under direction.
Coordinates 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, department and client meetings, and in maintaining an orderly and safe laboratory environment.
Recognizes and solves analytical and product problems.
Conducts and documents investigations.
Reviews laboratory documentation for calculation, entry and GMP compliance.
Solves complex, non-routine analytical and product problems independently.
Coordinates the documentation of laboratory experimentation in protocols and technical reports.
Assures that kitting is performed correctly in accordance with the methods in use.
Assures that all analysts and technicians keep the materials in good condition for their use in the analytical field, guaranteeing their conservation under the conditions indicated in the corresponding documentation.
Collaborates in the evaluation of the materials to be purchased for the assigned analytical activity and related documentation.
Takes care of the tools, materials and work environment, promptly communicating any anomalies to the Team Leader.
In compliance with company procedures, 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 In-depth knowledge of the most common analytical techniques and required instrumentation (HPLC, FT-IR, UV-VIS, Physical tests etc.)
Experience in Analytical Method Development/Transfer and Validation Knowledge of company procedures and GMPs Knowledge of laboratory computer programs Ability to work in a team Skill in people management BS required/MS preferred in a science related field and 2-3 years of laboratory experience, preferably in a pharmaceutical, biotechnology, healthcare, research, or academic environment English proficiency Personality Traits: Flexibility Good organization and planning skills Listening and communication skills Ability to work in a team At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell.
Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Join us
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