Loading

20 similar job(s) found

Loading

Quality Control Scientist

add review
Rating submitted

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.

Quality Control Scientist

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 (100%)

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 and verification, transfers, improvement projects and supports complex multi-sites investigations.

Essential duties and responsabilities

  • Comply with GMP requirements, Takeda policies 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 or verification 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 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
  • At least 5 years of experience in GMP pharma business activities, preferably in the scope of recombinant therapeutic product in pharmaceutical environment
  • More than 2 years of experience in GMP laboratory activities
  • Proven experience and knowledge in analytical method validation and verification
  • Good knowledge of critical reagent qualification
  • Experience in problem solving (facilitation and application of DMAIC tools) and deviation management
  • Strong knowledge of regulatory requirements concerning analytical test methods and licenses
  • Fluent in French and English (C1 written and spoken)

Qualifications

  • Proficiency in all aspects of standard IT tools
  • Good Knowledge of advanced statistical tools (i.e. 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

Address

Route de Pierre-à-Bot 111 2000 Neuchâtel

Website https://www.takeda.com/fr-fr

Add review

Enter your rating for the company Takeda Neuchâtel here!

Rating submitted