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
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Lead and coordinate analytical method transfer activities to or between Quality Control laboratories and external contract manufacturers
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Act as SME (Subject Matter Expert) for analytical issues during technology transfer and commercial manufacturing of drug substances and drug products
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Perform scientific troubleshooting for analytical methods (e.g., HPLC, GC, spectroscopy) in response to OOS, OOT, and atypical results
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Support CMOs/CDMOs in establishing analytical methods, resolving analytical challenges, ensuring alignment with internal standards and regulatory dossiers
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In case of method transfer by revalidation: design, optimize, and validate analytical methods according to ICH guidelines and GMP requirements
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Review and approve method transfer protocols, validation reports, and analytical documentation
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Drive root cause analysis and define CAPAs for analytical deviations in collaboration with cross-functional teams
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Ensure consistent method lifecycle management, including continuous improvement and robustness enhancement
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Support regulatory submissions by preparing and reviewing analytical sections (e.g., CTD Module 3) for new laboratories and CMOs
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Act as a key interface for Analytical Science & Method Transfer between Technology transfer team, Quality Assurance, Regulatory Affairs, and external partners
Core Expertise
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Analytical method transfer strategies (internal labs and CMOs)
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Analytical method development, validation, and lifecycle management
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Advanced analytical techniques:
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HPLC / UPLC
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GC
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Dissolution
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Spectroscopy
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Troubleshooting & deviation management (OOS/OOT investigations)
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Data evaluation
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GMP, ICH guidelines, and regulatory compliance
Professional Skills
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Experience working with contract manufacturers (CMOs/CDMOs) in a global environment
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Strong scientific problem-solving and troubleshooting mindset
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Excellent communication skills for interfacing with internal teams and external partners
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Structured and results-driven project management capabilities
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High level of accountability, persistence, and attention to detail
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Ability to manage multiple priorities in a regulated environment
Qualifications
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Degree in Chemistry, Pharmaceutical Sciences, or related field (e.g., HTL, ETH, MSc or equivalent)
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Minimum 5 years of experience in analytical development or quality control within the pharmaceutical industry
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Proven track record in method transfer and analytical troubleshooting
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Solid knowledge of GMP, ICH, and ISO standards
