The Technical Services Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at my client's facility in Blanchardstown, Dublin. The Technical Specialist will provide processing expertise to support the technology transfer, process validation and routine commercial manufacturing for Upstream and/or Downstream manufacturing. The Technical Specialist will be responsible for providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility startup and process qualification. The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Process Owner for cell culture unit operations, Process Validation (PPQ), Process Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability.
Responsibilities:
* To provide process expertise in one, or both of the following disciplines:
o Upstream (Cell culture focus) to include media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification).
o Downstream: to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.
* Author and review process documentation, gap assessments, protocols, reports, and validation documents.
* Identify requirements and oversee laboratory studies for process fit and transfer, liaising with Global Process Development.
* Support new material introductions through material lists, Bills of Materials, specifications, and testing requirements.
* Collaborate with Quality, Supply Chain, and Manufacturing Operations for material availability and release.
* Implement process improvements for yield and cycle time reduction.
* Generate documentation and lead plant and technical studies at commercial scale.
* Provide on-call support and occasional off-hours work during engineering and validation batches.
* Troubleshoot processing issues and lead investigations into process deviations.
* Lead process changes using change control systems.
* Ensure compliance with Quality, Safety, corporate standards, and support during audits.
* Ensure EHS policy, cGMP compliance, and participate in risk assessments and audits.
* Author and review CTD sections for regulatory submissions.
* Act as SME during regulatory inspections for technology transfer and process support.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Science, Accounting/Auditing, and Engineering
Industries
* Pharmaceutical Manufacturing
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