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Tech Transfer Lead

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Tipperary
  • Sector: Other
  • Date posted: 09/04/2018
  • Job reference: J384429A

Tech Transfer Lead

Tech Transfer Lead required to join a leading pharmaceutical manufacturing company in Tipperary.

The primary function of this role is to be a key driver of the Tech Transfer between the Lab Scale Development team in the US and the commercial site scale-up team in Ireland with specific responsibility for formulation scale-up.

Responsibilities:

  • The Formulation Lead, Tech Transfer fulfils a critical role in supporting the development and scale-up to commercial scale of dry powder and metered dose inhaler Inhalation products.
  • As a part of the global Inhalation Development team, the individual is involved in formulation and process development, in-vitro bioequivalence studies, characterisation of active ingredients and excipients, evaluation and selection of container closure systems, manufacturing and analysis of exhibit and stability batches, and product characterisation studies.
  • In collaboration with Lab Scale inhalation team and commercial site scale-up team, plan and execute scientific experiments to develop robust formulation processes (mixing/blending etc.) for inhalation projects.
  • 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.
  • In collaboration with US based inhalation team engage in formulation analysis and conduct product characterization studies and analytical aerosol testing. Strong background in in-vitro bioequivalence studies is required.
  • In collaboration with Lab Scale inhalation team and commercial site scale-up team compile results from all development studies in scientific reports. Contribute to the compilation of the relevant CMC sections for regulatory filing.
  • Support the maintenance of a safe and compliant work place.

Qualifications/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) in Inhalation (single/multiple dose DPIs and MDIs, dose counters and human factor assessments acquired through academic training plus on-the-job experience).
  • 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
  • Ability to interact effectively with management and others in group, project teams and personnel at manufacturing sites and CMOs.
  • Ability to manage multiple and complex projects.
  • Superior written and oral communication skills.
  • Team player with strong interpersonal skills able to work in networks across cultures and geographies.
  • Prepared to travel internationally (Europe, US).

For more info on this role contact Paul on 01 6455 250 or email paul.oconnorATexperis.ie

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