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.
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. DSP Technician The DSP Technician takes part in all the operational and documentation aspects of the DSP activities pertaining to the production of Bulk Drug Substance BDS under cGMP conditions.
Participate in the successful production of the BDS which includes the following
Support the organization of the pre-campaign period through involvement in the check list and raw material ordering
Assist in managing supplier relationships
Maintain spending within the pre-defined budget
Participate in the tech transfer process between Development and DSP
Participate in the TT work tox lots and drafting the corresponding documentation
Support the drafting review and finalization of all relevant documentation Master Batch Record Log Book etc.
Perform all the DSP operations within the BDS production campaign adhering to pre-defined timeline and procedures with a minimum of deviations
Ensure that all the actions related to DSP operations and necessary for the release of the batch are completed in a timely fashion
Support the timely close out of all deviations raised during the production runs
Participate in some occasional USP activities
Participate in the efficient coordination between the DSP team and the other Manufacturing/Quality/Process Development groups.
Regularly report all operational facts results and issues to the Head of Manufacturing and the persons in charge of the DSP team.
Assist Site Engineer in the maintenance and qualification of DSP equipment.
Assist in the organization of regular meetings drafting of minutes and timely follow up of actions.
Perform CAPAs following internal or external audits.
Work during weekends may be required as part of the regular responsibilities.
Perform other duties as required.
CFC or equivalent in biochemistry biology or chemistry as well as 1-3 years of applicable experience preferably in a GMP or GLP production environment
Relevant industrial experience in DSP operations both development and manufacturing experience in USP a plus
Relevant cGMP experience with excellent knowledge of regulations and guidelines pertaining to cGMP
Excellent interpersonal and communication skills
Ability to work both independently as well as part of a team
Proven skills in organization problem analysis/solving and proactivity
Strong awareness of the level of excellence needed in the pharmaceutical industrial environment.
Fluency in French and business-level English both written and oral