Scientist, Analytical Science & Method Transfer — CSL Behring
- Lieu
- Bern
- Contrat
- full-time
- Publié
- Hier
Vue d’ensemble du poste
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
Responsabilités principales
- 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
Exigences principales
- 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
Entreprise et contexte
- 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.
Détails supplémentaires
- 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
Notes et contenu original
- 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
Questions sur cette offre
Quel salaire propose CSL Behring pour ce poste ?
CSL Behring indique CHF 77 000 - 116 500 bruts par an pour ce poste à Bern. Il s'agit du salaire publié dans l'annonce d'origine (ou, si l'employeur ne précise pas de montant, d'une estimation réaliste pour le rôle et le secteur) — le calculateur de ce site le convertit en net réel une fois l'impôt frontalier et les cotisations sociales appliqués.
Est-ce un poste à temps plein, et quel type de contrat propose CSL Behring ?
Cette offre est un poste en temps plein. Le type de contrat affiché ici provient directement de l'annonce originale de l'employeur ; confirmez toujours les horaires exacts, le préavis et la durée d'essai avec CSL Behring pendant le processus de candidature, ces détails pouvant varier même au sein de la même catégorie de contrat.
Ai-je besoin d'un permis de frontalier pour un poste dans le canton de Berne ?
Les résidents UE/AELE domiciliés dans la zone frontalière du pays voisin du canton de Berne peuvent demander un permis G ; l'employeur suisse le dépose auprès de l'office cantonal des migrations après signature du contrat. Les règles de zone frontalière et les délais varient selon le pays voisin et le canton — confirmez les détails auprès de l'office des migrations du canton de Berne ou avec les RH pendant la candidature.
Comment postuler à ce poste chez CSL Behring ?
Utilisez le bouton « Postuler maintenant » sur cette page — il renvoie directement à l'annonce originale de CSL Behring sur csl.wd1.myworkdayjobs.com, votre candidature arrive donc directement dans le système de suivi des candidatures de l'employeur. Frontaliere Ticino ne collecte ni ne transmet lui-même les candidatures.
