Clinical Trial Manufacturing Scientist

1 settimana fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
**SCOPO DELLA POSIZIONE/RESPONSABILITÀ**:
Seguire il Tech Transfer e lo sviluppo di processo dei prodotti del reparto Pharmaceutical Development Service (P, selezionare i materiali necessari e decidere il process flow della manifattura.

Regolare i tempi necessari alla manifattura e supportare la Produzione per un'efficace schedulazione delle attività.

Redigere la documentazione di processo a supporto della Produzione, avendo la responsabilità di seguirne la fase di revisione ed approvazione.

Assume la piena responsabilità per la gestione técnica del lavoro di progetto assegnato.

**COMPITI SPECIFICI/ATTIVITÀ PRIMARIE**:

- Preparare la documentazione técnica necessaria per supportare il processo di fabbricazione in accordo alle NBF e alle SOP interne.
- Partecipare alla produzione di lotti clinici/commerciali all'interno del reparto sterile PDS.
- Seguire il Technology Transfer da parte del cliente al PDS e da Patheon ad altri siti produttivi, se richiesto.
- Effettuare le attività di competenza, il controllo dello stato di avanzamento delle stesse, il tutto attraverso la corretta programmazione delle attività quotidiane, nel rispetto delle priorità definite dal proprio superiore e degli standard di qualità aziendali.
- Assicurare la corretta gestione della documentazione di competenza, assicurare inoltre l'archiviazione e la rintracciabilità del dato, sia esso di origine interno che esterno, secondo le procedure vigenti, gli standard qualitativi aziendali ed in compliance con i relativi protocolli.
- Contribuire, nel rispetto degli standard aziendali, all'ottimale addestramento tecnico del personale di laboratorio sia in fase di inserimento, sia in occasione dell'introduzione di nuove tecnologie.
- Discutere con i Clienti lo stato di avanzamento delle attività proponendo soluzioni tecniche ove necessario e previsto.
- Supportare il laboratorio per la generazione di dati a supporto dello sviluppo del processo manifatturiero.
- Partecipare al disegno e sviluppo dei processi supportando le attività di sviluppo formulativo e del processo di liofilizzazione.

**RAPPORTI**:
**Interni**
- Process Development
- Operations
- Analytical Development
- Formulation Development
- Quality Assurance
- Project Manager

**Esterni**
- Clienti

**REQUISITI E QUALIFICHE**:
**(A) ESSENZIALI**

**Studi/Diplomi/Corsi di formazione**:

- Laurea in CTF, Chimica, Ingegneria o Chimica con esperienza

**Conoscenze tecniche e informatiche**:

- Conoscenza delle cGMP
- Conoscenza dei principali software

**Esperienze professionali**:

- Esperienza nel processo di sviluppo e di fabbricazione di prodotti sterile liquidi e liofilizzati

**Lingue**:

- Inglese

**Tratti di personalità**:

- Leadership
- Autonomia
- Responsabilità

  • Clinical Trial Manufacturing Scientist

    1 settimana fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer We provide our global teams with the resources needed to achieve individual career goals while...

  • Manufacturing Process Tecnologist

    1 settimana fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving...

  • Stage Manufacturing Process Scientist

    1 settimana fa

    Monza, Lombardia, Italia Adecco Italia A tempo pieno

    Andrà a supportare il gruppo dei Process scientist nell'esecuzione delle seguenti attività:- supporto nella compilazione della documentazione a supporto delle attività di produzione in accordo a procedure di sito- creazione ed autorizzazione dei codici materiali e della documentazione di produzione su sistema informativo- partecipare agli incontri...

  • Msat Scientist

    1 settimana fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving analytical challenges, growing productivity in their laboratories, improving patient...

  • Pds Ctm Intern

    1 settimana fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories,...

  • Supervisor, Manufacturing

    1 settimana fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving...

  • Mrna Scientist

    1 settimana fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories,...

  • Mrna Scientist

    1 settimana fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing productivity in their laboratories, improving...

  • Analytical Scientist, Manufacturing Sciences

    1 settimana fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    **Responsabilità**In accordo con il Supervisore, ha la responsabilità per i progetti assegnati di supervisionare ed eseguire (ove richiesto) tutte le analisi chimiche di laboratorio relative ad API/DS, ai semilavorati ed ai prodotti finiti. Assicura un'opportuna comunicazione con i clienti relativamente alle attività analitiche seguite. Ha la...

  • Lead Operator, Manufacturing

    1 mese fa

    Monza, Lombardia, Italia ThermoFisher Scientific A tempo pieno

    Job DescriptionThermo Fisher Scientific, a leading company in the field of Science, is in search of a Manufacturing Lead Operator for its PDS Business Unit.The selected individual will work in a department where Visual Inspection, both semi-automatic and manual, of sterile medications in vials (liquid and lyophilized form) or pre-filled syringes is carried...

  • Scientist I, Process and Analytical Development

    2 mesi fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Job DescriptionWe are seeking two highly motivated candidates for the role of Junior Scientists in the mRNA Process, Analytical and LNP Formulation Development team in Monza (Italy). The candidates shall have strong ability in upstream/downstream process development and are expected to work in a fast-paced environment with high self-motivation. The Junior...

  • Pds Analytical Development and Gmp Intern

    1 settimana fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    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 people the...

  • CMC Services Regulatory Affairs Specialist

    4 settimane fa

    Monza, Lombardia, Italia ThermoFisher Scientific A tempo pieno

    Job DescriptionThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their...

  • CMC Services Regulatory Affairs Specialist

    1 mese fa

    Monza, Lombardia, Italia ThermoFisher Scientific A tempo pieno

    Job DescriptionThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their...

  • Regulatory Compliance

    1 settimana fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving...

  • Team Leader PDS MBR

    1 settimana fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    The pharmaceutical manufacturing plant in Monza is specialized in commercial contract manufacturing of injectable drugs, both liquid and lyophilized, with an increasing focus on biologics. You will play a crucial role in leading and managing the Master Batch Record team within our dynamic organization. You will be responsible for overseeing the daily...

  • Master Batch Record Specialist

    8 ore fa

    Monza, Lombardia, Italia ThermoFisher Scientific A tempo pieno

    Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical...

  • Process & Cleaning Validation Specialist

    1 settimana fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that...

  • Manager, Quality Engineer

    4 settimane fa

    Monza, Lombardia, Italia ThermoFisher Scientific A tempo pieno

    Job DescriptionWhen you join us at Thermo Fisher Scientific, you'll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the most significant investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.SCOPE OF...

  • Manager, Quality Engineer

    1 mese fa

    Monza, Lombardia, Italia ThermoFisher Scientific A tempo pieno

    Job DescriptionWhen you join us at Thermo Fisher Scientific, you'll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the most significant investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.SCOPE OF...