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Technical Services Specialist

  1. Dublin
  1. Contract
Competitive
26757/NK
  1. Commisions, Qualification and Validation
Date Posted30 Apr 2021
Techinical Services Specialist - Contract - Dublin

Technical Services Specialist opportunity to work for a global Biotech Company in Dublin. Experience working with CMOs highly desirable. 

Remote work at the start and could change to on-site. Up to 20% International Travel may be required.

Duties:
  • Provide significant technical expertise to support all aspects of the manufacturing of commercial and cell culture derived biopharmaceutical products at CMOs.
  • Lead troubleshooting efforts and high-level deviation investigations in conjunction with CMOs and internal partners (Process Development, Manufacturing, and Quality).
  • Support all aspects of the manufacturing process from cell culture through downstream processing, testing and release.
  • Technical review of change controls for impact to product quality, safety and efficacy.
  • Provide on-floor technical support and troubleshooting at the CMO facility.
  • Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
  • Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities.
  • Collection, organisation, trending, and analysis of GMP manufacturing data.
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
  • Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
  • Up to 20% international travel may be required.
 

Skills:    
  • Minimum 1-3 years’ experience in providing technical support to biologics drug substance manufacturing
  • Knowledge of mammalian cell culture and purification unit operations.
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing and the ability to implement best practices
  • Experience of working with CMOs would be a distinct advantage, demonstrating strong communication and influencing skills.
 
Education:         
  • Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
For more information, apply with a copy of your up to date CV today!

The candidate must have the rights to work in the location stated in the job advert.

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