Scientist, Analytical Science & Method Transfer — CSL Behring
- Location
- Bern
- Contract
- full-time
- Posted
- Yesterday
Role overview
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
Main responsibilities
- 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
Key requirements
- 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
Company and context
- 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.
Additional 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
Notes and original content
- 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 about this listing
What salary does CSL Behring offer for this role?
CSL Behring lists CHF 77'000 - 116'500 gross per year for this position in Bern. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does CSL Behring offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with CSL Behring during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Bern?
EU/EFTA residents living in the border zone of the country adjoining Canton Bern can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Bern's cantonal migration office or with HR during the application.
How do I apply for this position at CSL Behring?
Use the "Apply now" button on this page — it links directly to CSL Behring's original listing at csl.wd1.myworkdayjobs.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
