Technical Services Specialist
- Dublin
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
Technical Services Specialist opportunity to work for a global Biotech Company in Dublin. Experience working with CMOs highly desirable.
Remote work at the start and could change to on-site. Up to 20% International Travel may be required.
Duties:
- 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).
- Support all aspects of the manufacturing process from cell culture through downstream processing, testing and release.
- 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.
Skills:
- Minimum 1-3 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.
Education:
- Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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