QC Lead Immunology (Biologics Group)
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Our client, a leading global biopharmaceutical organisation, is seeking to hire a QC Lead Immunology to be based in Switzerland.
This position serves as a point of client contact for Quality Control/Analytical aspects of a project from beginning to end with accountability for assigned project deliverables.
Key responsibilities include:
- Develop and lead external or internal technology transfer projects into the Quality Control department.
- Responsible for the execution of analytical immunology test method transfer, optimization and validation to meet project requirements.
- Identify and track critical path/activities and risks, develop contingency and alternative plans and provide regular updates to CMC program lead, project management and Head of Quality Control on immunological methods.
- Assist CMC Program Lead, project management and Head of Quality Unit to ensure that resources assigned to the project shall deliver according to expectations and client satisfaction.
- Manage project strategy, objectives, specifications, deliverables, timelines and tasks with respect to immunological analytics.
- Work with CMC program lead, project management and Head of Quality Control to ensure resources are committed and available to execute.
- Track action items, prepare meeting agendas, coordinate team activities and disseminate project information.
- Establish and monitor project goals as well as go/no-go criteria for all key decision points.
- Write and review test method transfer and validation protocols and reports (including development reports and similarity/comparability assessments) as required.
The ideal candidate will be able to demonstrate the following key criteria:
- PhD or equivalent immunology, biochemical engineering, biochemistry, biology or related discipline
- Proven experience in functional and binding ELISA
- Relevant biologics experience in an industrial setting under GMP standards; CMO experience is a plus
- Relevant process and QC experience and knowledge of current analytical techniques
- Excellent communication skills and strong diplomacy skills required
- Fluency in English, both written and verbal; French is a plus
- Proven ability to work with flexibility in a changing and demanding environment
- Ability to work independently as well as part of a team
- Demonstrated success with problem analysis/solving, anticipation and proactivity
- Strong sense of discipline and initiative, exceptional planning and organization skills, excellent team orientation and a hands-on approach to work
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Chidozie Orji on +44 (0)207 4400 671 or upload your CV on our website www.proclinical.jobs . Full job description available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies