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Shire QC Group Leader Microbiology in Neuchatel (Baxalta), Switzerland
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 Group Leader Microbiology .
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 manufacturing environment.
Supervise, in collaboration with the QC Manager, the Microbiology Laboratory in charge of microbiological tests of IPC and raw material samples to ensure reliable and timely availability of test results under cGMP. This position will be a back up to the Manager in his function of management and documents approval.
Essential duties and responsabilities
Supervise the Microbiology Laboratory activities to assure timely availability and accuracy of results.
Ensure that all samples are analyzed in accordance with SOPs and regulatory requirements to applicable GMPs and standards.
Ensure timely release of the analysis
Enforce all safety policies and practices
Technical expertise of different microbiological methods (bioburden, bacterial endotoxin test,…)
Conduct Gemba walk (GMP, EHS,etc)
Conduct adequate Laboratory investigations when issues arise. Participate or lead a team when appropriate for the investigation process
Event/CAPA owner, investigator
Ensure audit readiness in Laboratory, subjects preparation and presentation during audit
Drives continuous improvement in the lab (5S)
Definition of daily priorities for the laboratory
Supervise and participate to the validation activities of the Laboratory
Ensure timely availability of required testing capabilities and supportive documentation
Ensure that the status of equipment and procedures are compliant.
Support implementation and validation of new methods
Supervise in collaboration with the QC Manager the Microbiology Laboratory
Drive performance management
Define Roles and Responsabilities within the team
Coach and develop team members
Ensure training of lab technicians
Ensure the motivation of the team
Education & Experience
Master degree in biotechnology or biochemistry or equivalent
Expertise in microbiological methods
3 - 5 years of experience in microbiological laboratory activities
Experience in GMP activities in a pharmaceutical environment, preferably in the scope of recombinant therapeutic product
Experience in people management is an advantage
Fluent in French and English (B2 written and spoken)
Excellent computer skills
Able to synthesize information and defend conclusions publically
Able to give and receive constructive feedback
Able to set his/her own priorities and tight timelines according to the customers’ needs
Good communicate with customers and suppliers (external and internal)
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
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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, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.