Scientist, Analytical Science & Method Transfer — CSL Behring
- Ort
- Bern
- Vertrag
- full-time
- Veröffentlicht
- Heute
Rollenüberblick
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
Hauptaufgaben
- 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
Wichtige Anforderungen
- 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
Unternehmen und Kontext
- 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.
Weitere Details
- 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
Notizen und Originalinhalt
- 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
Fragen zu dieser Stellenanzeige
Welches Gehalt bietet CSL Behring für diese Stelle?
CSL Behring gibt CHF 77'000 - 116'500 brutto pro Jahr für diese Position in Bern an. Dies ist das im Original-Inserat veröffentlichte Gehalt (oder, falls der Arbeitgeber keinen Betrag nennt, eine realistische Schätzung für Rolle und Branche) — der Rechner auf dieser Seite berechnet daraus Ihr tatsächliches Netto nach Grenzgänger-Steuer und Sozialabgaben.
Ist das eine Vollzeitstelle, und welchen Vertragstyp bietet CSL Behring?
Diese Stelle ist eine Vollzeit-Position. Der hier angezeigte Vertragstyp stammt direkt aus dem Original-Inserat des Arbeitgebers; klären Sie genaue Arbeitszeiten, Kündigungsfrist und Probezeit während des Bewerbungsprozesses mit CSL Behring, da diese Details auch innerhalb derselben Vertragskategorie variieren können.
Brauche ich eine Grenzgänger-Bewilligung für eine Stelle im Kanton Bern?
EU/EFTA-Bürger mit Wohnsitz in der Grenzzone des an den Kanton Bern angrenzenden Landes können eine G-Bewilligung beantragen; der Schweizer Arbeitgeber reicht sie nach Vertragsunterzeichnung beim Migrationsamt dieses Kantons ein. Grenzzonen-Regeln und Bearbeitungszeiten variieren je nach Nachbarland und Kanton — klären Sie die Details mit dem Migrationsamt des Kantons Bern oder mit HR während der Bewerbung.
Wie bewerbe ich mich für diese Stelle bei CSL Behring?
Nutzen Sie die Schaltfläche "Jetzt bewerben" auf dieser Seite — sie führt direkt zum Original-Inserat von CSL Behring unter csl.wd1.myworkdayjobs.com, sodass Ihre Bewerbung direkt im Bewerbermanagementsystem des Arbeitgebers landet. Frontaliere Ticino sammelt oder leitet keine Bewerbungen selbst weiter.
