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Manufacturing Technology Manager

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Dublin
  • Sector: Engineering
  • Date posted: 29/09/2017
  • Job reference: J373918A

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Manufacturing Technology API Manager

My Client is seeking to recruit an MT API Manager, on a permanent basis for our Manufacturing Technology group based in Dublin. The Manufacturing Technology group is responsible for the provision of technical expertise in the areas of API, Intermediate and Starting Material production, Drug Product, Sterile Manufacturing, Packaging and Medical Devices for products manufactured in an external manufacturing environment.

The MT API Manager role requires demonstrated experience of the technical management of processes relating to the manufacture of small molecule API and corresponding intermediate materials in an external manufacturing environment.

Responsibilities will include (but not limited to):

  • Leadership and accountability for the technology transfers, including ownership of the overall delivery timelines and associated project management to ensure all campaign goals are met (e.g. safety, quality, analytical timelines, knowledge etc.)
  • Working with all relevant departments to coordinate technology transfer activities. Partner closely with the R&D group, based in New Jersey, through clinical manufacture and validation to transfer manufacturing processes to our external commercial sites (CMOs).
  • Partner with product development (R&D) to ensure new products under development are designed for robust commercial manufacture.
  • Assessing manufacturing requirements and capabilities prior to the transfer of a new process into manufacturing facilities and providing floor support during the validation campaigns, as well as review of process data to ensure operational consistency.
  • Supporting CMO/vendor selection - preparation of technical information packages, leading technical due diligence and site assessments, technical evaluation of RFIs and RFPs.
  • Preparation, distribution and presentation of project status reports to project team members and management. Review and approval of technology documents such as Technology Transfer plans, Validation Master plans, process risk assessments etc.
  • Providing manufacturing descriptions and technical evaluations for regulatory filings, and provides technical support to address Health Authority questions and inspections.

  • Ensuring robust process performance at our CMOs post the transfer. Identifying and executing process robustness improvement projects, where required. Technical leadership for process monitoring, control and continuous improvement strategy and management.
  • Technical leadership for the externally manufactured APIs, Intermediates and Starting Materials, ensuring consistent security of supply into launch.
  • Providing technical leadership in the understanding of root causes for out of trend or out of specification results or deviations for API or intermediate manufacturing processes.
  • Provide technical leadership for change management, investigation CAPA identification and related activities at CMO site.
  • Driving the use of strategies, resources and processes (OPEX) to improve processing efficiency and to ensure optimised technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.

Qualifications and Experience required:

  • A graduate or post-graduate level qualification in chemistry, chemical engineering or related field. Ideally a Ph.D. qualification in Chemistry, preferably synthetic organic chemistry.
  • Relevant pharmaceutical development or manufacturing experience (ideally > 7 years) is essential. Experience in leading new product introduction is desirable.
  • Recognised technical leader and subject matter expert in API process development and scale-up, technology transfer, process management, trouble-shooting and optimisation, and relevant synthesis and degradation chemistry.
  • Demonstrated project management and technical leadership capability. Ability to build effective teams made up of diverse contributors.
  • Solid experience in commercial manufacturing of API in accordance with GMP standards in an external manufacturing environment.
  • Thorough knowledge and understanding of process, engineering, analytical and regulatory requirements (cGMP, filing, EHS).
  • Demonstrated capability to lead complex technical investigations and in the use of standard tools for root cause analysis.
  • Thorough understanding of statistical process analysis and control methods. Experience in using Statistical software packages.
  • Confident management of internal and external stakeholder relationships.
  • Excellent communication and negotiation skills are required for this position as well as the ability to translate technical issues into business impact and relevant solutions.

The position will require varying levels of travel - estimated to average less than 30

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