Scientist, Analytical Science & Method Transfer

Biopharma Careers; Sankt Gallen; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

CSL Vifor in St. Gallen is seeking an experienced analytical science professional focused on method transfer and validation across CMOs/CDMOs under GMP conditions.

You will report to the CMC Strategy and Technology Transfer Lead and lead troubleshooting, CAPA definition, and collaboration with QA, Regulatory Affairs, and external partners.

Qualifikationen

• Minimum 5 years of experience in analytical development or QC within the pharmaceutical industry.
• Proven track record in method transfer and analytical troubleshooting.
• Solid knowledge of GMP, ICH, and ISO standards.
• Experience coordinating with CMOs/CDMOs.

Aufgaben

• Lead analytical method transfer activities with QC labs and external CMOs.
• Act as SME for analytical issues during technology transfer.
• Troubleshoot analytical methods for OOS/OOT results.
• Support CMOs in establishing and validating methods per regulatory standards.
• Review method transfer protocols and validation reports.
• Drive CAPAs and continuous improvement in method lifecycle management.

Kenntnisse

Analytical method transfer

Method validation

Troubleshooting

Data evaluation

Regulatory compliance

Cross-functional collaboration

Ausbildung

Degree in Chemistry/Pharmaceutical Sciences

Tools

HPLC

UPLC

GC

Dissolution

Spectroscopy

Jobbeschreibung

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.

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
• Act as a key interface for Analytical Science & Method Transfer between Technology transfer team, Quality Assurance, Regulatory Affairs, and external partners

Core Expertise

• Analytical method transfer strategies (internal labs and CMOs)
• Analytical method development, validation, and lifecycle management
• Advanced analytical techniques:
  • HPLC / UPLC
  • GC
  • Dissolution
  • Spectroscopy
• Troubleshooting & deviation management (OOS/OOT investigations)
• Data evaluation
• GMP, ICH guidelines, and regulatory compliance

Professional Skills

• Experience working with contract manufacturers (CMOs/CDMOs) in a global environment
• Strong scientific problem-solving and troubleshooting mindset
• Excellent communication skills for interfacing with internal teams and external partners
• Structured and results-driven project management capabilities
• High level of accountability, persistence, and attention to detail
• Ability to manage multiple priorities in a regulated environment

Qualifications

• 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 at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement .