Experience:
• University or engineering degree in analytical chemistry, biotechnology, biochemistry
• 1 or 2 years of experience in GMP pharma business activities, preferably in the scope of recombinant therapeutic product in pharmaceutical environment
• Experience in GMP Laboratory activities
• Good knowledge of method transfer
• Good knowledge of critical reagent qualification
• Experience in problem solving and deviation management
• Good Knowledge of statistical tools
• Fluent in French and English (C1 written and spoken)
• Proficiency in all aspects of standard IT tools

The job holder is accountable for life cycle management activities of analytical assays performed in the QC Laboratories of Neuchâtel – Switzerland with a focus on:
• Laboratory Investigations
• Critical Material Qualification
• Laboratory Method Transfers
In addition, the job holder also supports daily QC activities following cGMP.

Validation and Qualification Activities
• Author transfer protocols and reports for assays
• Author qualification plans and reports for critical reagents
• Oversee validation and qualification activities executed by analysts, provide
training and support
• Execute and documents experiments

Investigation Leads
• Investigate and trouble shoot problems which occur to determine solutions or
recommendations for improvements or change
• Conduct/participate in risk assessments, root cause analysis and investigations
• Own Laboratory Investigations and CAPA

Quality Control Support Activities
• Support the application of industry specific compliance standards/regulations to
assays life cycle management activities
• Participate to daily activities upon request (provide technical and statistical
support)

Competencies
• Excellent collaboration skills and teamwork mindset
• Good trouble shooting and problem-solving skills
• Ability to work independently in a fast-paced environment
• Ability to manage multiple priorities and know when to escalate issues for resolution
• Effective communicator
• Demonstrated ability to synthesize information
• Demonstrated ability to give and receive feedback

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