shire is the leading global Biotechnology company focused on serving people with rare diseases and other highly specialized conditions. we strive to develop best-in-class products, many of which are available in more than 100 countries, across core Therapeutic Areas including Hematology, Immunology, Neuroscience, ophthalmic, lysosomal storage disorders, gastrointestinal/Internal medicine/endocrine and hereditary angioedema; and a growing franchise in oncology. in 2016, shire grew its organization to approximately 24,000 employees+ globally, following integrations of dyax and baxalta.
an exciting and challenging opportunity has become available at shire neuchâtel plant (approx. 650 employees) for a qc Scientist.
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 local qc, 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 scientists from global qc and analytical development groups
Education & experience
- University or Engineering degree in Analytical Chemistry, Biotechnology, Biochemistry or Microbiology
- min 3 years of experience in GMP Laboratory activities, preferably in the scope of recombinant therapeutic product in Pharmaceutical environment
- 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 (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
living our Leadership behaviors is a basic expectation for all shire employees. shire expects all employees to embody the following:
- be positive
- be accountable
- be results oriented
- be an excellent manager of self and others
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