Analytical Development
6 mesi fa
**Work Schedule**
Other
**Environmental Conditions**
Office
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.
Reporting to the PDS AD&GMP Supervisor they are responsible for the assigned projects, responsible for all the documentation related to QC PDS Laboratory in such a way as to ensure the successful continuation of the projects within the PDS.
Collaborates with all the functions within the company in the implementation of analytical requirments respecting the company quality standards.
Collaborate for the analytical documentation of APIs, Excipients and DP (release and stability tests), preparing the analytical method and supporting the upload of these on the computerized systems.
Collaborate with Clients, QC PDS, Regulatory Department, QC Compliance, QA and QO in order to issue the correct documents for PDS projects, respecting the ICH and Pharmacopoeia.
You will a part, supported by the QC Documentation Team, of discussion about compliance consulting and strategic advice to internal and external clients to determine the most appropriate approach in order to have compliant documentation for their products.
Will be a part, supported by the QC Documentation Team, to project specific strategy, technical expertise in QC Documentation matter and collaboration oversight for key client’s projects. With the QC Documentation team will be an executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relation functions. Ensures quality performance for key/managed projects.
In this role will be part of a cohesive team responsible for Deviations, CAPAs, and Change Controls for all phases of PDS Projects.
You will improve of analytical skills cGMP regulations to ensure full Quality compliance.
Works supporting the QC PDS Documentation Team performing work that consistently support Client’s expectation and respect of Client’s timelines.
Collaborate with the Team to plans for future customer activities and solicit other projects that are aligned with the company goals & objectives.
Contribute to updating the procedures relating to the area of competence, by drafting and reviewing them as needed, in compliance with current regulations, laws and GMP standards.
Contributes the continuous updating of the procedures concerning the area of competence in the drafting and updating of the same, in compliance with current regulations (current EU GMP, US GMP)
Support the Qc Documentation team to perform laboratory investigations, laboratory OOS and OOT and any deviations and CAPA related to the PDS Projects.
Collaborate for the evaluation of OOS, OOT and laboratory investigation in terms of recurrences, root cause, trend and define CAPAs.
**Relationships**:
**INTERIORS**
- Production departments
- QA
- Regulatory
- Logistics
- TT / Business
**Exterior**:
- Clients
- External laboratories
**Requirements and qualifications**:
- ** ESSENTIALS**
**Bachelor's degree in chemical engineering, chemistry, or equivalent degree**:
**Technical and IT knowledge**:
GMP standards applied to Quality Control laboratories, with particular reference to stability studies
**Knowledge of laboratory concepts and computer programs**:
Knowledge of data management and evaluation systems
**Professional experiences**:
In the laboratory of analysis at university or pharma companies
**Languages**:
English
**Personality traits**:
- Flexibility and adaptability.
- Good organization and planning skills
- Excellent listening, oral, and written 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.
-
Analytical Development Specialist
4 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob Description:As a key member of the Thermo Fisher Scientific team, you will play a vital role in the development and implementation of analytical methods and techniques for the pharmaceutical industry.Key Responsibilities:Coordinate and plan laboratory activities, ensuring compliance with Good Manufacturing Practices (GMP) and standard operating...
-
PDS Analytical Development Specialist
4 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout the Role:We are seeking a highly skilled PDS Analytical Development Specialist to join our team at Thermo Fisher Scientific. As a key member of our Pharmaceutical Development Services (PDS) team, you will be responsible for leading analytical development activities, ensuring compliance with GMP regulations, and collaborating with cross-functional teams...
-
PDS Analytical Development Expert
3 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob SummaryThermo Fisher Scientific is seeking a highly skilled PDS Analytical Development Expert to join our team. As a key member of our Pharmaceutical Development and Sciences (PDS) department, you will play a critical role in the development and implementation of analytical methods and strategies to support our customers' product development needs.Key...
-
Senior Analytical Development Scientist
1 mese fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob SummaryWe are seeking a highly skilled and experienced Analytical Development Scientist to join our team at Thermo Fisher Scientific. As a key member of our PDS Analytical Development & GMP Department, you will be responsible for developing and implementing analytical methods for small and large molecule analysis, as well as ensuring compliance with GMP...
-
Analytical Development Expert
4 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout the RoleAs a key member of the Analytical Development & GMP Department at Thermo Fisher Scientific, you will play a crucial role in supporting product development efforts and ensuring compliance with regulatory standards.Main ResponsibilitiesConduct testing of raw materials, in-process products, and finished products, adhering to SOPs and cGMP...
-
Senior Analytical Development Specialist
4 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout the RoleWe are seeking a skilled and experienced Senior Analytical Development Specialist to join our team at Thermo Fisher Scientific.Key ResponsibilitiesDevelop and implement analytical methods for pharmaceutical productsConduct stability and routine tests on APIs and finished productsLead the development and transfer of analytical methods, ensuring...
-
Analytical Development
1 mese fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWork Schedule OtherEnvironmental Conditions OfficeJob Description When you're part of Thermo Fisher Scientific, you'll do daring 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...
-
Analytical Development
4 settimane fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWork Schedule Other Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do daring 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...
-
Analytical Development
4 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWhen you’re part of Thermo Fisher Scientific, you’ll do daring 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...
-
Analytical Development
4 giorni fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWork Schedule OtherEnvironmental Conditions OfficeJob Description When you're part of Thermo Fisher Scientific, you'll do daring 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...
-
Analytical Development
1 giorno fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWork ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionWhen you're part of Thermo Fisher Scientific, you'll do daring 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...
-
Analytical Development
5 giorni fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWork ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionWhen you’re part of Thermo Fisher Scientific, you’ll do daring 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...
-
Pds Analytical Development Gmp Scientist
6 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWhen 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...
-
Analytical Development
3 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pieno**Work Schedule** Other **Environmental Conditions** Office When you’re part of Thermo Fisher Scientific, you’ll do daring 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...
-
Pds Analytical Development
6 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWhen 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...
-
Analytical Development
6 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWhen 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...
-
Pds Analytical Development
6 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pieno**Work Schedule** Other **Environmental Conditions** Office 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...
-
Pds Analytical Development
6 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWhen 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...
-
Analytical Scientist
4 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob Title: Analytical Development SpecialistAbout the Role:The successful candidate will join the Analytical Development GMP Department in a newly built Pharmaceutical Department (PDS).Main Responsibilities:Responsible for testing of raw materials (especially API), in-process finished product, formulations and according to SOPs.Analytical Method Development,...
-
Pds Analytical Development
4 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWork Schedule Other Environmental Conditions Office 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...
