Cache of job #13889418

Job Title

Formulation Lead

Employer

Brightwater

Location

Tipperary

Description

This is a great opportunity to join a start-up site in Tipperary with one of the worlds biggest generic pharma manufacturers. This is a rapidly expanding company who are dedicated to high end, speciality medications. At their state-of-the-art facility you`ll be part of a high performing team. You will fulfil a critical role in supporting the development and scale-up to commercial scale of products that will be transfered in from R&D. As a part of the global team, you`ll be involved in formulation and process development, in-vitro bioequivalence studies, characterization of active ingredients and excipients, evaluation and selection of container closure systems, manufacturing and analysis of exhibit and stability batches, and product characterization studies. Duties: Plan and execute scientific experiments to develop robust formulation processes (mixing/blending etc.) Provide technical and project leadership to Inhalation projects while being an individual contributor in a consistent, creative and innovative manner. Conduct manufacturing process development and technology transfer to ensure processes and related operating procedures are successfully developed and seamlessly transferred in to commercial production. Develop strategies for process scale-up and execute process validation. Engage in formulation analysis and conduct product characterization studies and analytical testing. Strong background in in-vitro bioequivalence studies is required. Compile results from all development studies in scientific reports. Support the maintenance of a safe and compliant work place. Requirements. At least 3-5 years of relevant experience. A strong and demonstrated knowledge of cGMP in formulation and analytical laboratory activities. Understanding of ICH and FDA guidance and regulatory requirements for drug product development and manufacturing. Strong knowledge of formulation and manufacturing sciences (product development, process research, scale-up and technology transfer. Experience in MDI and DPI formulation, manufacturing and testing is required. Experience in final dosage formulation. Experience in analytical testing of DPIs and MDIs, including in vitro BE studies, is expected. The ability to interact effectively with management and others in group, project teams and personnel at manufacturing sites and CMOs. The ability to manage multiple and complex projects. Superior written and oral communication skills. Willingness to travel internationally (Europe, US. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

Date Added

2166 days ago

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