QC Associate Scientist (m/w/d)

Branche: Biotech
Fähigkeiten: QC,Life Cycle Management

Projektstart: asap

Projektdauer: 12 months 

Einsatzort: Neuenburg, Schweiz

Duties:

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, Takeda policies and EHS  requirements.

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)

Experience:

• University or engineering degree in analytical chemistry, biotechnology, biochemistry, microbiological
• 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