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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Technical Services Manager


Reference:SCA014500 Location: Tipperary
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Manufacturing and Technology Manager, Scientist

Technical Services Manager
Our client a pharma company, are currently recruiting for a Technical Services Manager to join their team on a permanent basis. The ideal candidate will have tech transfer and commercial manufacturing experience. This role offers hybrid working. There will be some travel associated with this role.


Responsibilities:

  • Lead and support the technology transfer of new and existing drug product manufacturing processes and ensure timely completion of all technical transfer-related milestones
  • Work with R & D to facilitate the introduction and scale up of new products and support due diligence efforts for all process, manufacturing and validation activities
  • Lead the review of all GxP manufacturing and packaging documentation from contract manufacturing sites
  • Lead the review of all process validation/optimisation protocols and reports from contract manufacturing sites. Support dossier compilation and review for all new drug products
  • Liaise with other internal departments to ensure all necessary manufacturing documentation is implemented in a timely manner and in line with project plans
  • Perform continuous process verification (CPV) on the manufacturing process and identify any trends. Responsible for implementing changes identified from CPV, changes from cGMP standards requirements, process improvements or arising from corrective actions
  • Prepare, review, and approve relevant Standard Operating Procedures (SOPs) and other necessary GMP and GDP documents, for activities related to manufacturing operations, and support SOPs and policies
  • Technical review and compilation (as applicable) of all executed batch manufacturing documentation including manufacturing records, technology transfer protocols, technology transfer reports, process scale up protocols, process scale up reports, process optimisation protocols, process optimisation reports, process validation protocols and process validation reports
  • Conduct and support manufacturing process investigations to drive operational excellence and continuous improvement
  • Evaluate new suppliers from a technical manufacturing perspective
  • Ensure all commercial drug product is serialised in line with regulatory requirements
  • Ensure all commercial drug product is manufactured and released to supply chain plans

Requirements:
  • B.Sc. in a science related discipline (Chemistry, Engineering, Biotechnology, Pharmacy etc.) and 10 years relevant experience in a cGMP pharmaceutical manufacturing environment.
  • Experienced in multiple manufacturing process areas such as technology / product transfer, process scale up, process optimisation, process validation and routine manufacture
  • Extensive manufacturing experience with multiple dosage forms including but not limited to sterile, oral liquid and solid oral dosage products. On floor/in plant experience required. Working knowledge of Annex 1: Sterile Manufacture of Medicines is desirable
  • An exceptional track record in overseeing manufacturing projects under multiple deadlines
  • Supply chain knowledge is desirable
  • Experience working in high growth, fast paced environments
  • Professional English language skills are essential

For more information please contact Sinéad Cullen on +353879500821 or [email protected]