Senior Technical Specialist - Drug Substance (Bio) Dublin

Claran Consultants

Dublin
Description

Senior Technical Specialist required for a start up bio facility in Dublin. Minimum of five years’ experience in providing technical support to biologics drug substance manufacturing or a strong operations role. 12 month contract. Contact Ann 021 4701100

 


Senior Technical Specialist required for a start up bio facility in Dublin.  Minimum of five years’ experience in providing technical support to biologics drug substance manufacturing or a strong operations role.  12 month contract.  Contact Ann 021 4701100

 

Role:

  • Provide significant technical expertise to support all aspects of the manufacturing of commercial and late stage clinical biopharmaceutical products at CMOs or internally.
  • Lead troubleshooting efforts and high-level deviation investigations in conjunction with CMOs and internal partners (Process Development, Manufacturing, Quality, etc.)
  • Support all aspects of the manufacturing process from raw material selection and specification through upstream manufacture, 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 if required.
  • 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.
  • Support establishment of validation plans and evaluation of drug substance/product production site options
  • 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 required.
  • Any other duties required by Manager

Requirements:

  • Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field. Advanced degree would be an advantage.
  • Minimum of five years’ experience in providing technical support to biologics drug substance manufacturing or a strong operations role
  • Extensive knowledge of biologics manufacture, mammalian cell culture and purification unit operations.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing.
  • Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
  • Experience of technology transfers and scale-up.
  • Experience of working with CMOs would be a distinct advantage, demonstrating strong communication and influencing skills.