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R&D Sterile Process Lead, Waterford



Waterford, Ireland 

Job Category:

Biotech/Pharma, Engineering

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Job Description:

The Opportunity

Team Horizon is looking for a R&D Sterile Process Lead, to support the R&D department by providing significant fill-finish technical expertise to support all aspects of the manufacturing of sterile products.

The Role
  • Provide leadership, cross-functional development and technical expertise on the aseptic manufacture of biologics
  • Provide scientific/engineering leadership across all the disciplines involved in Technology Transfer and Sterile Operations
  • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure
  • SME for sterile formulation of biologic products
  • Support all aspects of the manufacturing process from formulation and filling to visual inspection
  • Technical review of change controls for impact to product quality, safety and efficacy
  • Provide on-floor technical support and troubleshooting
  • 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
  • Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process
  • Responsible for the activities necessary to execute the transfer and all testing to support the Technology Transfer process, as relevant to the Receiving Unit
  • Ensure information transfer to Process Engineering group for all cycle development activities
  • Review sampling plans for all activities and ensure compliance with all TT requirements
  • Support the generation of the Control Strategy
  • Ensuring that operational modifications or processing gaps are identified and updated in the operational control strategy
  • Oversee execution of technical studies and associated document preparation at the receiving unit
  • Lead technical feasibility review and technology gap analysis to ensure process / method fit within the unit’s technology capabilities
  • Approve validation protocols that will be used as part of technology transfer, as appropriate
The Person
  • Honours Degree level in an appropriate science or engineering discipline, preferably Biotechnology
  • Minimum five years’ experience in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection
  • Significant exposure to sterile operations and/or Tech Transfer projects
  • Experience in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices
  • Familiarity with protein handling and processing considerations
  • Extensive operational experience within aseptic filling lines and formulations areas
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Experience in cycle development of CIP/SIP/VHP cycles
  • Technical Primary pack knowledge and vendor knowledge (WEST, Schott, OMPI, etc.)
  • Proficiency in Microsoft Office and job related computer applications required
  • Knowledge of electronic document management system

Employment Type:

Full time
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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