Glenmark Pharmaceuticals (www.glenmarkpharma.com) is a research-led, global, fully integrated pharmaceutical company. The group is present in more than 90 countries including the USA and Europe. Our Swiss operation encompasses the Company’s Biological Research and Development Centre located in the Canton of Neuchâtel and focuses on the discovery and development of novel biological entities comprising monoclonal antibodies and proprietary bispecific format.
Quality Control Lead-Immunology
Glenmark Pharmaceuticals www.glenmarkpharma.com is a research-led global fully integrated pharmaceutical company. The group is present in more than 90 countries including the USA and Europe. Our Swiss operation encompasses the Company's Biological Research and Development Centre located in the Canton of Neuchâtel and focuses on the discovery and development of novel biological entities comprising monoclonal antibodies and proprietary bispecific format. Quality Control Lead-Immunology OVERVIEW
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. This role reports directly to the Head of the Quality Unit.
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.
Participate in project team meetings as assigned.
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.
Support Quality Control management to access/acquire required resources.
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.
Evaluate and capture the productivity and profitability of analytics and data initiatives.
Ensure relevant knowledge management and documentation management.
Manage regulatory feedback implementation plan with respect to immunological assays.
Support immunological analytical strategy including specification setting and characterization assessment adapted to development phase as per regulatory interactions/guideline interpretations.
Perform other relevant duties as required.
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