Technical Services Specialist

2021-11-02 14:45:422049-03-18Team Horizon
Job TypeContractor
SectorOperations & Manufacturing
Start Date
AdvertiserHilda Lynn
Job Ref#1002235
Job Views221
Technicial Services Specialist – Team Horizon
We are seeking applications for an experienced Technical Services Specialist to join our clients Bulk Drug Manufacturing facility in Dublin.
You will have primary responsibility for providing scientific & technical support of (cell culture derived) drug substance manufacturing processes, specifically the technology transfer of product(s) into the site.
Why you should apply:
  • This is an excellent opportunity to join a world class manufacturing operation, with an outstanding focus on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.
  • 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.
What you will be doing:
  • You will provide scientific and technical support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation, routine manufacturing, and process/continual improvement programs.
  • In this role you will be working cross-functionally with external contractors and internal partners including Manufacturing, Process Development, Engineering, Regulatory, QC and Quality to provide support of manufacturing of BDS.
  • Provide process information and analysis to facilitate process/facility fit, and qualification of a large scale BDS facility through to NPI tech transfer start-up, PPQ validation, in a multi-product BDS facility.
  • Participate in Tech Transfer Receiving Unit activities, and provide technical guidance to team members in large scale cell culture/downstream purification processes, and provide SME support for the area on key audit topics.
  • Provide scientific and technical input to facilitate decision making related to Tech Transfer.
  • Provide/develop deep technical knowledge and understanding in cell culture processes; vial thaw, seed expansion, seed reactors and large-scale production bioreactors, including centrifugation and depth filtration steps, or downstream purification processes; large scale column chromatography steps, ultrafiltration/diafiltration steps, pH adjustment, depth/nanofiltration steps, and final fill. 
  • Undertake technical risk assessments to support raw material assessment for NPI, working on Mass balance; development of materials listing/BOM’s to support process.
  • Provide SME knowledge and understanding in BDS manufacturing processes (upstream/downstream); cause and effect, scale up principles, QRM, and process validation strategies.
  • Shape and develop strategy approaches for Technical Services in areas such as cell culture and downstream purification processes, technical studies supporting facility fit and regulatory filings, Technology Transfer, PPQ, CPV approach and so forth ensuring alignment to industry regulations, trends and advances.
  • Collaborate with Process Development and Engineering to influence the design and implementation of a robust process control strategy, complete process risk assessments and associated documentation to support equipment qualification activities, PPQ studies and key technical strategies.
  • Perform risk assessments to support the technology transfer e.g., pFMEA’s and other risk tools.
  • Provide Technical input, review/approval into documentation associated with New Material Introduction, Manufacturing control and enterprises systems (MCS/MES) including manufacturing batch records, work instructions, competencies, and other related technical documentation.
  • Requirement to work periodically out of normal business hours (temporary shift working or per out of hours policy) during periods of engineering and validation batch execution, and participation in on-call roster.
  • Short duration Person in Plant (PIP) observation may be required at sending units/existing facilities to support Tech Transfer into the site.
  • Author, review and approval of protocols, and reports which may support CMC sections for regulatory agency submissions and responses (as required).
  • Contribute to successful regulatory agency inspections by providing subject-matter expertise on mammalian cell culture/downstream purification, technology transfer and manufacturing processes.
What you need to apply:
  • A passion for GMP Manufacturing and all things large molecules.
  • Ideally you will have a minimum of 2-3 years+ experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations or downstream unit operations, process/facility fit, New Product Introduction Technology Transfer.
  • Previous experience of a technology transfer in a cell culture capacity is advantageous.
  • An advanced degree (MS, PhD) in Scientific (Biochemistry, Biology, Chemistry, Pharmacy) or Engineering (Chemical, Mechanical) related field is desirable but we are happy to consider applicants with an undergraduate degree in chemistry, biology, engineering or related discipline.
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