QC Scientist
Dyax Corp.
Neuchatel, CH
vor 11 Tg.

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.

    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 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)
  • Qualifications

  • 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 Accountable
  • Be Results Oriented
  • Be An Excellent Manager of Self and Others
  • Bewerben
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