Pharmaceutical Development Specialist

6 ore fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

About Us

At Thermo Fisher Scientific, we're a global leader in serving science. With our extensive portfolio of products and services, we enable customers to make the world healthier, cleaner and safer.

Our Team

We value performance, quality, and innovation. Our team is encouraged to perform at their best, with access to resources and opportunities to create significant contributions.

The Role

We're seeking a skilled Pharmaceutical Development Specialist to join our PDS Analytical Development & GMP Department. As a key member of our team, you'll be responsible for assigned projects, ensuring successful project continuation within the department.

Responsibilities

  • Responsible for analytical documentation of APIs, excipients, and DP (release and stability tests)
  • Collaborate with clients, QC PDS, regulatory department, QC compliance, QA, and QO to issue correct documents for PDS projects, adhering to ICH and pharmacopoeia guidelines
  • Provide compliance consulting and strategic advice to internal and external clients on compliant documentation for their products
  • Develop project-specific strategies, technical expertise in QC documentation matters, and coordinate oversight for key client projects
  • Serve as executive contact for key clients, attending regulatory authority meetings and public relation functions, ensuring quality performance for managed projects
  • Evaluate OOS, OOT, and laboratory investigations in terms of recurrences, root cause, trend, and define CAPAs
  • Perform laboratory investigations, OOS, and OOT, and any deviations and CAPA related to them, collaborating with supervisor and team leader

Requirements

To succeed in this role, you'll need:

  • Bachelor's degree in chemical engineering, chemistry, or equivalent work experience with pharmaceutical companies
  • GMP standards applied to Quality Control laboratories, particularly referring to stability studies, laboratory data management, and SOP writing
  • English and Italian language proficiency
  • Flexibility, adaptability, good organization, and planning skills
  • Excellent listening, oral, and written communication skills
  • Ability to work in a team

Estimated Salary Range: $90,000 - $120,000 per year, depending on qualifications and location. We offer a comprehensive benefits package, including health insurance, retirement plans, and paid time off.



  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Job SummaryThe Pharmaceutical Process Specialist - Aseptic Operations will coordinate and oversee the technology transfer and scale-up of new pharmaceutical products in our commercial manufacturing departments, ensuring client satisfaction and business growth.Key Responsibilities:Coordinate with internal functions to process client project requirements.Lead...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Job Title: Pharmaceutical Process SpecialistAs a key member of the Thermo Fisher Scientific team, you will be responsible for designing, validating, and ensuring the regulatory approval of life-saving and innovative drugs. Your contributions will make a significant difference in the quality of our pharmaceutical products. Responsibilities:• Work closely...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Job TitlePharmaceutical Manufacturing Talent Acquisition SpecialistAbout the RoleWe are seeking a skilled and experienced Recruiter to join our team in Monza, Italy. As a Pharmaceutical Manufacturing Talent Acquisition Specialist, you will be responsible for recruiting top talent for various roles across our Italian sites.Key ResponsibilitiesPartner with...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Project Management Role for Pharmaceutical DevelopmentWe are seeking a highly skilled Project Manager to join our Pharmaceutical Development team at Thermo Fisher Scientific. As a key member of our project management team, you will be responsible for overseeing PDS projects from initiation to completion, ensuring timely and budget-friendly delivery of...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Job OverviewWe are seeking a highly skilled and experienced Senior Pharmaceutical Quality Assurance Specialist to join our PDS Business unit at Thermo Fisher Scientific Inc. As a key member of our team, you will play a vital role in ensuring compliance with current US GMP, EU GMP regulations, and our company's outstanding quality standards.


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    The Research and Development Assistant will play a crucial role in supporting the Scientist in managing activities necessary for the execution of projects related to sterile pharmaceutical products. Key responsibilities include selecting and managing materials for production, loading/approval of manufacturing documentation into the system, and writing...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Job SummaryThermo Fisher Scientific Inc. is seeking a highly skilled Senior Pharmaceutical Project Coordinator to play a pivotal role in a dynamic, international environment at our Monza site. This role offers an outstanding opportunity to engage with world-class pharmaceutical manufacturing and development, particularly in aseptic injectable drugs and...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule Standard (Mon-Fri) Environmental Conditions Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office What Makes This Opportunity Unique At Thermo Fisher Scientific, we provide a highly collaborative and multifaceted environment where you can excel and make a meaningful...

  • Project Manager

    6 ore fa


    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific is a leading life sciences company, driving innovation to make the world a healthier, cleaner, and safer place. With annual revenue exceeding $40 billion, we empower our customers to accelerate their research, solve complex analytical challenges, and improve patient health through diagnostics and therapies.**Job Summary**We are...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Job DescriptionWe are seeking a skilled Scientific Development Specialist to join our team at Thermo Fisher Scientific. The ideal candidate will have a strong background in analytical techniques and instrumentation, with experience in method development and validation.


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    About UsThermo Fisher Scientific is a global organization with revenues exceeding $40 billion. We invest heavily in research and development, providing our team members with the resources and opportunities to make significant contributions to the world.">Job SummaryWe are seeking an experienced Recruiter for our Pharmaceutical Manufacturing team. The...


  • Monza, Lombardia, Italia Mygwork A tempo pieno

    About UsThermo Fisher Scientific Inc. is a leading science industry company, generating over $40 billion in annual revenue. Our mission is to enhance the world's well-being by providing solutions for various scientific needs.We offer innovative technologies, convenient purchasing options, and pharmaceutical services through our industry-leading brands...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Job Description:At Thermo Fisher Scientific, we are seeking a highly skilled Technical Business Development Specialist to support our business management team with commercial clients. The ideal candidate will have excellent analytical thinking and be business-oriented, with the ability to build and maintain relationships internally and with customers.About...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Job Summary: We are seeking a highly skilled Quality Specialist to join our team at Thermo Fisher Scientific. The successful candidate will play a key role in ensuring compliance with current US GMP, EU GMP regulations, and our company's outstanding quality standards.Key Responsibilities:Assure constant monitoring of sterile production lines to ensure...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule StandardEnvironmental Conditions:Our cleanroom environment requires adherence to strict guidelines, including prohibition on hair products, jewelry, makeup, nail polish, perfume, and exposed piercings.Job Description:We are seeking a highly skilled Sterility Assurance Specialist to join our APS Sterility team at Thermo Fisher Scientific...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    **Descrizione del Lavoro:**Nella nostra squadra di Pharmaceutical Development Service (PDS) a Monza, impegnata nella produzione di prodotti iniettabili destinati alla sperimentazione clinica, cerchiamo un Specialista QA del Progetto che si occupi delle attività seguenti:• Controllo dei Lotti per Rilascio: Collaborare con la QP e il Quality Operations...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    **About the Role**Thermo Fisher Scientific is a world leader in serving science. We are seeking a highly skilled Manufacturing Validation Specialist to join our team in Monza, Italy. This role will be part of the Quality Unit, responsible for process validation of new products manufacturing.The estimated annual salary for this position is approximately...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to support the registration process of our Patheon Monza site as a manufacturer of sterile medicinal products in major markets.About the RoleThis is an excellent opportunity to work on regulatory strategies, collaborate with clients, and ensure compliance with marketing authorization...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Job DescriptionWe are seeking a highly skilled Senior Portfolio Management Specialist to join our team at Thermo Fisher Scientific.About the RoleThis is a fantastic opportunity to work on overseeing and supporting Monza Site Projects Portfolio to ensure that site improvement projects are completed on time and budget. As a Senior Portfolio Management...


  • Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Selezionato per entrare a far parte dell'unità Pharmaceutical Development Service (PDS) della nostra sede di Monza, interamente dedicata alla produzione di prodotti iniettabili finalizzati alla sperimentazione clinica. In qualità di QA Project Specialist ti occuperai delle seguenti attività:Compiti Principali**Controllo lotti per rilascio**: Supporterai...