MSAT Technical Lead - Drug Substance - Biologics — Sobi
- Località
- Basel
- Contratto
- full-time
- Pubblicato
- Ieri
Panoramica
Science and Technology (SAT) is part of the Global CMC, Science & Technology Department (GCSAT).
- Science and Technology (SAT) is part of the Global CMC, Science & Technology Department (GCSAT).
- Main responsibilities:
- Subject matter expert (SME) for DS Biologics manufacturing.
Responsabilità principali
- Main responsibilities:
- Subject matter expert (SME) for DS Biologics manufacturing.
- Process owner of DS Biologics validation for Sobi products.
- Lead and execute MSAT projects such as manufacturing process and cost improvement as part of life-cycle management (LCM).
- Participate in and lead internal activities related to (external) manufacturing such as process changes, major/critical deviations, risk assessments and CAPAs.
- Issue, review and approve applicable internal and external SOP’s and manufacturing instructions.
- Review and supervise set up, execution and documentation of technical studies, qualifications and validations.
- Write and review applicable sections of the APR/PQR.
- Write and review applicable sections in registration files, variations and market expansion, as well as answer Health authorities requests and questions.
- Support in sourcing evaluation of new DS Biologics contract manufacturers and participation in developing supply and quality agreements.
Processo di candidatura
- Travelling up to 30% of the time. How to apply
- We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible.
- Click apply and include your resume in English.
- Why Join Us?
- Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team: Emphasis on work/life balance
- Collaborative and team-oriented environment Opportunities for professional growth Diversity and Inclusion Competitive compensation for your work
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
- We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate.
Azienda e contesto
- GCSAT is a growing organization, responsible for optimization and life cycle management of Sobi’s clinical and commercial manufacturing and analytical processes in our external network.
- SAT ensures compliant, reliable, cost effective and sustainable manufacturing and testing of our products now and in future.
- The SAT team holds the senior scientific and technical knowledge for the manufacturing and analytical testing of Sobi’s clinical and commercial products and is responsible for always keeping processes in a validated stage.
- The Technical Lead is pivotal in ensuring technical excellence, regulatory compliance, and the continuous improvement of manufacturing processes.
- The incumbent will drive cross-functional collaboration to support the launch and lifecycle management of products, technology transfers, and the implementation of innovative methodologies
Dettagli ulteriori
- Travelling up to 30% of the time.
- Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team: Emphasis on work/life balance
- Collaborative and team-oriented environment Opportunities for professional growth Diversity and Inclusion Competitive compensation for your work
Note e contenuto originale
- How to apply
- Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Competitive compensation for your work
Domande frequenti su questo annuncio
Che stipendio offre Sobi per questa posizione?
Sobi indica CHF 85'500 - 129'500 lordi annui per questo ruolo a Basel. Questo è lo stipendio pubblicato nell'annuncio originale (o, quando il datore non specifica una cifra, una stima realistica per ruolo e settore) — il calcolatore di questo sito lo converte nel netto reale una volta applicate imposta da frontaliere e contributi sociali.
È un ruolo a tempo pieno, e che tipo di contratto offre Sobi?
Questo annuncio è una posizione a tempo pieno. Il tipo di contratto mostrato qui arriva direttamente dall'annuncio originale del datore di lavoro; conferma sempre orario esatto, preavviso e durata del periodo di prova con Sobi durante il colloquio, perché questi dettagli possono variare anche all'interno della stessa categoria contrattuale.
Serve un permesso da frontaliere per un ruolo nel canton Basilea?
I residenti UE/AELS nella zona di frontiera del paese confinante con il canton Basilea possono richiedere il Permesso G; il datore di lavoro svizzero lo presenta all'ufficio della migrazione di quel canton dopo la firma del contratto. Regole sulla zona di frontiera e tempi di lavorazione variano per paese confinante e canton — verifica i dettagli con l'ufficio della migrazione del canton Basilea o con HR durante il colloquio.
Come mi candido a questa posizione presso Sobi?
Usa il pulsante "Candidati ora" in questa pagina — rimanda direttamente all'annuncio originale di Sobi su jobs.smartrecruiters.com, quindi la tua candidatura arriva direttamente nel sistema di gestione candidature del datore di lavoro. Frontaliere Ticino non raccoglie né inoltra candidature in proprio.