QC SCIENTIST (6-MONTH FIXED TERM CONTRACT)
takeda
Neuchâtel, Switzerland
vor 5 Tg.

Takeda Neuchâtel

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.

Job summary

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)
  • Qualifications

  • 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
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