Job Responsibilities
* Develop and support the analytical method life cycle management strategy for in-process, release, and stability testing of commercial products.
* Lead multisite assay transfers by providing an assay transfer strategy and project management with internal and external laboratories.
* Serve as a subject matter expert for analytical methods including biological, molecular biological, and microbiological methods established in commercial release testing laboratories.
* Take ownership of analytical issues and drive closure quickly, correctly, and permanently for commercial products.
* Serve as an in-house analytical/technical expert for troubleshooting and investigating laboratory issues.
* Apply statistical analysis for data interpretation and apply chemometric principles to resolve complex analytical issues and applications.
* Represent Quality Control on technical product teams.
* Collaborate closely with in-house analytical/process technical experts for troubleshooting and investigating laboratory and manufacturing issues.
* Author, review, and approve method validation/transfer protocols/reports, related SOPs, quality control plans, qualification protocols/reports, re-test protocols/reports of critical reagents for analytical methods, and regulatory relevant documents related to analytical methods.
* Coordinate and lead re-manufacturing of critical reagents for analytical methods.
* Responsible for technical assessment of methods and changes to methods for compliance with GMP requirements, global Pharmacopeias, industry standards, etc.
* Create and enhance collaborative and trusting relationships with internal and external laboratories and internal SMEs, and establish effective communication.
* Organize and lead cross-functional team meetings with internal and external laboratories and SMEs.
Requirements
* Bachelor's degree in microbiology, pharmaceutical science, biotechnology, chemistry, or a closely related field with a minimum of 5 years of experience within a QC laboratory or QA organization (with oversight of QC activities).
* A thorough understanding of pharmaceutical QM Systems and respective guidelines and QC laboratory processes is required; experience in an outsourced manufacturing and testing environment is preferred.
* Experience in vaccines and biologics manufacturing and testing, and related guidelines, along with knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements, preferred.
* Strong technical expertise in microbiology and microbial methods and instrumentation, and statistical methods for data analyses.
* Experienced at leading and delivering successful Technology Transfer activities across the CMO and internal network.
* Fluency in English is required; German is beneficial.
* EU Citizenship or a valid Swiss Work Permit is required.