Biopharma QC Scientist
View: 167
Update day: 20-03-2024
Location: Neuchâtel Neuchâtel NE
Category: Pharmaceutical / Chemical / Biotech
Industry: Pharmaceutique et biotechnologie
Job content
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Job Description
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
Locations
CHE - NeuchatelWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeDeadline: 04-05-2024
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