Scientist, Analytical Science & Method Transfer

CSL Plasma Inc.; Sankt Gallen; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

CSL Vifor in Switzerland is seeking an experienced analytical science professional focused on analytical method validation and transfer to CMOs/CDMOs under GMP conditions. You will coordinate method transfers, act as SME, and troubleshoot analytical challenges across external labs while ensuring alignment with regulatory dossiers.

You will report to the CMC Strategy and Technology Transfer Lead and collaborate with QA, Regulatory Affairs, and cross-functional teams to drive robust analytical

Qualifikationen

• Minimum 5 years in analytical development or quality control in pharma/biotech.
• Proven track record in method transfer and troubleshooting.
• Solid knowledge of GMP, ICH and ISO standards.

Aufgaben

• Lead and coordinate analytical method transfer activities to internal labs and CMOs/CDMOs.
• Act as SME for analytical issues during technology transfer and manufacturing.
• Troubleshoot analytical methods (HPLC/UPLC/GC/spectroscopy) in response to OOS/OOT.
• Support CMOs/CDMOs in establishing analytical methods and regulatory dossiers.
• Design, optimize, and validate methods per ICH and GMP in case of revalidation.
• Review transfer protocols, validation reports, and documentation.
• Drive root cause analysis and define CAPAs with cross-functional teams.
• Ensure method lifecycle management and continuous improvement.
• Support regulatory submissions with analytical sections (CTD Module 3).
• Interface between Technology Transfer, QA, Regulatory, and external partners.

Kenntnisse

Analytical method transfer

Troubleshooting

Root cause analysis

Cross-functional collaboration

Scientific problem solving

Regulatory compliance

Ausbildung

Degree in Chemistry or Pharmaceutical Sciences

5+ years in analytical development or quality control

GMP/ICH/ISO knowledge

Tools

HPLC

UPLC

GC

Spectroscopy

Dissolution

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. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

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. 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 click here.

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