Site de Production Biotech Biotech Manufacturing Site
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do.
We live our values of Takeda-ism Integrity, Fairness, Honesty, and Perseverance and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives including your own.
QC SCIENTIST (6-MONTH FIXED TERM CONTRACT)
This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Quality Control teams within a world-class Biotech GMP manufacturing environment.
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.
In addition, the job holder also leads laboratory method validations, transfers, improvement projects and supports complex multi-sites investigations.
Essential duties and responsabilities
Comply with GMP requirements and applicable QC procedures
Identify and facilitate / lead problem-solving and improvement projects using DMAIC approach
Investigation owner and coordinator (out-of-specification, out-of-limit, and out-of-trend analytical results, and other types of investigations)
Responsible for writing validation protocols and reports for analytical methods
Responsible for writing qualification plans and reports for critical reagents and reference standards
Oversee validation and qualification activities executed by QC analysts, provide training and support
Support of analytical method transfers as transferring or receiving unit between R&D and Analytical Laboratories as well as within Operations
Write assignment plans and reports for method controls, establish and perform evaluation of control charts
Support and preparation of audits, audit responses and regulatory submissions
Participate in multi-site projects as local project lead, working in collaboration with other QC scientists and Analytical Development groups
Education & Experience
University or engineering degree in analytical chemistry, biotechnology or biochemistry
Good skills in microbiology field is a plus
Min 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 analytical method validation and critical reagent qualification
Experience in problem solving (facilitation and application of DMAIC tools)
Good knowledge of regulatory requirements concerning analytical test methods and licenses
Fluent in French and English (C1 written and spoken)
Excellent computer skills (Word, Excel, Power Point, MS Project)
Knowledge of advanced statistical tools hypothesis / relationship testing, control charting, capability, design of experiments, multivariate data analysis)
Able to set his / her own priorities and tight timelines
Good interpersonal, organizational, and communication skills
Ability to synthesize information and defend conclusions publically