Scientist, Analytical Science & Method Transfer — CSL Behring
- Località
- Bern
- Contratto
- full-time
- Pubblicato
- Ieri
Panoramica
We are currently looking for an experienced analytical science professional specializing in analytical method validation and transfer to contract manufacturing organizations (CMOs/CDMOs). Strong focus on troubleshooting, root-cause investigation, and ensuring robust analytical performance across external laboratories and CMOs under GMP conditions. In this position you will be directly reporting to the CMC Strategy and Technology Transfer Lead.
- Lead and coordinate analytical method transfer activities to or between Quality Control laboratories and external contract manufacturers
- Act as SME (Subject Matter Expert) for analytical issues during technology transfer and commercial manufacturing of drug substances and drug products
- Perform scientific troubleshooting for analytical methods (e.g., HPLC, GC, spectroscopy) in response to OOS, OOT, and atypical results
- Support CMOs/CDMOs in establishing analytical methods, resolving analytical challenges, ensuring alignment with internal standards and regulatory dossiers
- In case of method transfer by revalidation: design, optimize, and validate analytical methods according to ICH guidelines and GMP requirements
- Review and approve method transfer protocols, validation reports, and analytical documentation
- Drive root cause analysis and define CAPAs for analytical deviations in collaboration with cross-functional teams
- Ensure consistent method lifecycle management, including continuous improvement and robustness enhancement
- Support regulatory submissions by preparing and reviewing analytical sections (e.g., CTD Module 3) for new laboratories and CMOs
- Key Responsibilities
- Lead and coordinate analytical method transfer activities to or between Quality Control laboratories and external contract manufacturers
- Degree in Chemistry, Pharmaceutical Sciences, or related field (e.g., HTL, ETH, MSc or equivalent)
- Minimum 5 years of experience in analytical development or quality control within the pharmaceutical industry
Responsabilità principali
- Key Responsibilities
- Lead and coordinate analytical method transfer activities to or between Quality Control laboratories and external contract manufacturers
- Act as SME (Subject Matter Expert) for analytical issues during technology transfer and commercial manufacturing of drug substances and drug products
- Perform scientific troubleshooting for analytical methods (e.g., HPLC, GC, spectroscopy) in response to OOS, OOT, and atypical results
- Support CMOs/CDMOs in establishing analytical methods, resolving analytical challenges, ensuring alignment with internal standards and regulatory dossiers
- In case of method transfer by revalidation: design, optimize, and validate analytical methods according to ICH guidelines and GMP requirements
- Review and approve method transfer protocols, validation reports, and analytical documentation
- Drive root cause analysis and define CAPAs for analytical deviations in collaboration with cross-functional teams
- Ensure consistent method lifecycle management, including continuous improvement and robustness enhancement
- Support regulatory submissions by preparing and reviewing analytical sections (e.g., CTD Module 3) for new laboratories and CMOs
Requisiti principali
- Degree in Chemistry, Pharmaceutical Sciences, or related field (e.g., HTL, ETH, MSc or equivalent)
- Minimum 5 years of experience in analytical development or quality control within the pharmaceutical industry
- Proven track record in method transfer and analytical troubleshooting
- Solid knowledge of GMP, ICH, and ISO standards About CSL Vifor
- CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology.
- We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives.
- Headquartered in St.
- Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).
- The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.
- To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ . Our Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL . You Belong at CSL At CSL, Inclusion and Belonging is
Azienda e contesto
- We are currently looking for an experienced analytical science professional specializing in analytical method validation and transfer to contract manufacturing organizations (CMOs/CDMOs).
- Strong focus on troubleshooting, root-cause investigation, and ensuring robust analytical performance across external laboratories and CMOs under GMP conditions.
- In this position you will be directly reporting to the CMC Strategy and Technology Transfer Lead.
Dettagli ulteriori
- Act as a key interface for Analytical Science & Method Transfer between Technology transfer team, Quality Assurance, Regulatory Affairs, and external partners
- Analytical method development, validation, and lifecycle management Advanced analytical techniques:
- Troubleshooting & deviation management (OOS/OOT investigations)
- GMP, ICH guidelines, and regulatory compliance Professional Skills
- Solid knowledge of GMP, ICH, and ISO standards
- To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL . At CSL, Inclusion and Belonging is
Note e contenuto originale
- Core Expertise
- Analytical method development, validation, and lifecycle management
- Advanced analytical techniques:
- Dissolution
- Spectroscopy
- Data evaluation
- GMP, ICH guidelines, and regulatory compliance
- Professional Skills
- Qualifications
- About CSL Vifor
Domande frequenti su questo annuncio
Che stipendio offre CSL Behring per questa posizione?
CSL Behring indica CHF 77'000 - 116'500 lordi annui per questo ruolo a Bern. 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 CSL Behring?
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 CSL Behring 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 Berna?
I residenti UE/AELS nella zona di frontiera del paese confinante con il canton Berna 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 Berna o con HR durante il colloquio.
Come mi candido a questa posizione presso CSL Behring?
Usa il pulsante "Candidati ora" in questa pagina — rimanda direttamente all'annuncio originale di CSL Behring su csl.wd1.myworkdayjobs.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.
