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Process Development Scientist II, Dublin



Dublin, Ireland 

Job Category:

Biotech/Pharma, Science

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Job Description:

We are seeking applications for an experienced Process Development Scientist II for our client, who is a leading biopharmaceutical company based in Dublin.

The successful candidate has primary responsibility for providing technical support of commercial and clinical drug substance and drug product manufacturing operations performed at contract manufacturing organisations (CMOs). The successful candidate will be responsible for providing scientific and engineering support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation and routine commercial or clinical manufacturing. The position requires effective cross-functional collaboration with external contractors and internal partners including Manufacturing, Process Development, Engineering, and Quality to provide support of manufacturing

Why you should apply:

  • This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  • There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
  • Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

  • 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.
  • Provide technical oversight and direction for transferring new products and processes to commercial
  • CMO sites.
  • Identify and 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

What you need to apply:

  • 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.
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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