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 Results Oriented
Be An Excellent Manager of Self and Others