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Process Scientist - Upstream / Downstream

I8012

Both Upstream & Downstream Technical Specialists required in support of a new drug substance technology transfer at a Dublin based BioPharmaceutical facility.

Category:
Chemist Industrial
Location:
Leinster
Years of Experience Req.:
2years+
Date Posted:
26/03/2020
Days Remaining:
113
Employment Type:
Contract
Education Level Req.:
Third level qualification

Process Scientist - Upstream / Downstream  

Both Upstream & Downstream Technical Specialists required in support of a new drug substance technology transfer at a Dublin based BioPharmaceutical facility.

The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Technology Transfer, Process Validation (PPQ), Process Monitoringb & Risk Assessments.

Upstream Candidates:

  • To provide process expertise in the area of buffer/media preparation & large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors).
  • Working knowledge of typical cell culture unit operations, cause and effect, product expression, in-process tests.
  • Author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents.
  • Identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to oversee the design and execution of studies.
  • To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements
  • To identify and implement process improvements; e.g. yield, cycle time reduction.
  • To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution

 

Downstream Candidates:

  • To provide process expertise in the area of buffer preparation & large scale protein purification drug substance manufacturing process (column chromatography, VI, UFDF/TFF, Viral filtration and bulk fill).
  • Working knowledge of typical chromatography and filtration unit operations and functional purpose, cause and effect, in-process tests, and mass balance principles. 
  • Author and review process transfer documentation, gap assessments, technical protocols and reports, including process validation documentation & strategy documents.
  • Generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale. 
  • Provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution with CAPAs. 
  • Lead any key process changes using change control management system.
  • Technical and operational knowledge of multiple unit operations in downstream protein purification processing (chromatography, filtration, TFF).
  • In-depth technical and operational knowledge of multiple unit operations in downstream processing, including buffer preparation, industrial scale protein purification, TFF filtration, final fill, nano and process filtration.
  • Strong understanding of technology transfer, scale-up process and cleaning validation.

 

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