Specialist Technical Services
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | EngineeringOperations & Manufacturing |
| Start Date | |
| Advertiser | Esther Emmanuel |
| Job Ref | #1002421 |
| Job Views | 293 |
- Description
- Specialist Technical Services - Team Horizon
We have an exciting opportunity available for a Specialist Technical Services to work on our client’s pharmaceutical site in Dublin.In this role you will provide significant technical expertise to support all aspects of the manufacturing of commercial and cell culture derived biopharmaceutical products at CMOs. Lead troubleshooting efforts and high-level deviation investigations in conjunction with CMOs and internal partners (Process Development, Manufacturing, and Quality). As well as support all aspects of the manufacturing process from cell culture through downstream processing, testing and release.
Why you should apply:
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
The role is generously compensated and attracts a competitive base salary and highly attractive benefits package.
Excellent career progression opportunities.
What you will be doing:
Technical review of change controls for impact to product quality, safety and efficacy.
Provide on-floor technical support and troubleshooting at the CMO facility.
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.
Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
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 may be required.
What you need to apply:
Minimum of three years’ experience in providing technical support to biologics drug substance manufacturing
Knowledge of mammalian cell culture and purification unit operations.
Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing and the ability to implement best practices
Experience of working with CMOs would be a distinct advantage, demonstrating strong communication and influencing skills.
Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.