Technical Services Manager

This speciality healthcare company focuses on improving patient’s lives while creating value through developing, manufacturing, marketing, and distributing a broad portfolio of products through its numerous operating companies. Founded in 1997, the company has since expanded to include the following business segments: U.S. Branded Pharmaceuticals, U.S. Generic Pharmaceuticals, Devices, and International Pharmaceuticals. Headquartered in Dublin, Ireland, this organisation is rapidly looking to expand its operations here. As a result, a new requirement in the business for a Technical Services Manager has arisen.

The Role

Reporting into the Director for Technical Operations, the Technical Services Manager will be responsible for managing the coordination and execution of all technical operations activities for all internal and external manufactured products to ensure reliable product supply and quality. This will include technical analysis and assessment of internal and external manufacturing capabilities, process robustness, designing, implementing and executing FMEAs. Scope of work will include manufacturing and packaging commercial operations, technology transfers, process validation, new product launches, second source qualifications and cost savings initiatives. This position requires working closely with Business Development, Research & Development, Manufacturing, Engineering, Regulatory Affairs and Quality Assurance teams.

Responsibilities will include:

  • Being the functional subject matter expert responsible for the execution of all product specific technical assessments and equipment capabilities, leading the identification of technical issues, troubleshooting and problem solving
  • Reviewing and where appropriate, signing/approving technical documents (MBRs, MPRs, Protocols, Change Controls) and CMC documents to support development, submission, and on-going manufacture of all assigned products
  • Directing the identification of opportunities for process robustness improvements and process capability improvements at CMOs; leveraging local technical expertise and working with CMOs functional counter-part to complete specified work
  • Holding responsibility for technical analysis of product complaints and recommended CAPAs/changes
  • Providing detailed and thorough technical assessment, analysis, and recommendation for any manufacturing investigation, as well as Providing Impact Assessment of internal or CMO initiative Change Controls

The Person

In order to be considered you must possess the following:

  • Education – BS in Chemical Engineering, Chemistry, Pharmacy or related scientific field
  • 10 years relevant experience in the pharmaceutical industry or related field or an advanced degree with a minimum of 7 years’ experience
  • An understanding of the current pharmaceutical technologies and manufacturing equipment; technology transfer and scale-up, testing, validation, and packaging
  • Knowledge and understanding of formulation development of solid/liquid dosage forms desirable
  • Hold an EU passport / Eligible to live and work within the EU

To find out more apply on line or call Gillian McMurrough at HRM on +353 1 6321827 for a confidential discussion.

Salary: €63000 - €78000 Location: Dublin South