Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Attività principali:

• Stesura e revisione documenti GMP per Process Validation, quali ad esempio: PPQ Master Plan, PPQ protocol e report, protocolli e report per studi supportivi alla validazione, gap e impact assessment report, anlisi del rischio e identificazione parametri critici di processo, valutazione specifiche di processo e analitiche, raccolta e analisi dati.
• Collaborazione con le unità di GMP manufacturing, QA e QC per revisione dei documenti MBR, PTS e sampling plan
• Supporto nella revisione di dossier regolatori e assessment degli stessi da parte degli enti regolatori
• Supporto a MSAT Compliance nella valutazione di change control, CAPA e deviazioni
• Interazione e discussione tecnica con i Clienti dell’azienda.
• Supporto nelle ispezioni da parte dei Clienti e degli entri regolatori

Requisiti:

• Laurea in Biotecnologie o similari
• Almeno 2 anni di esperienza in ruolo analogo
• Forte attitudine al problem solving e capacità di lavorare in team
• Buona capacità di analisi critica dei dati e dei processi
• Flessibilità e adattamento nei cambi di strategia di un progetto
• Buona conoscenza dell’inglese parlato e scritto
• Buona competenza di scrittura documenti

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on
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AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances

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