Technical Services Specialist
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| Job Type | Contractor |
| Location | Athlone |
| Area | Westmeath, Ireland |
| Sector | Engineering |
| Start Date | |
| Advertiser | Hilda Lynn |
| Job Ref | #1001919 |
| Job Views | 191 |
- Description
- We are seeking applications for an experienced to provide technical support to clinical biologics start up at our client new manufacturing facility. The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Technology Transfer, supporting start-up studies, building process data packs, and performing process monitoring, study protocol generation, execution and report writing. The position requires effective cross-functional working relationships with Manufacturing, Engineering, Facilities, Logistics, Quality Assurance and Quality Control groups which support day-to-day operations; interacting with Process Development and Analytical sciences for introduction of new products; and providing support for Regulatory submissions to ensure successful facility start up and process qualification.
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:
Provide significant technical expertise to support all aspects of the mammalian bulk drug substance cell culture and purification manufacturing at the biologics facility.
Process SME to support commissioning, automation, and manufacturing operation teams.
Support technology transfers of new products into the facility
Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.).
SME for introduction of single use systems and assessment of their use in terms of extractables, leachables.
To author and review process supporting documentation, process descriptions, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications.
To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
Technical review of change controls for impact to product quality, safety, and efficacy.
Provide on-floor technical support and troubleshooting.
Partner with Operations to support protocol completion, execution, and sample reconciliation.
To generate documentation reports for technical studies
Lead any key process changes using change control management system as required.
Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
Ensure compliance with site EHS policy, cGMP, and other business regulations.
What you need to apply:
Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field
Experience in technical services support in the manufacture of mammalian drug substance cell culture and purification and/or process development and/or manufacturing support
Experienced in relevant unit operations including vial thaw and scale up, seed train and production bioreactors, harvest, chromatography, UF/DF, viral filtration and inactivation, final formulation and media and buffer preparations.
Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices.
Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically in the manufacture of mammalian bulk drug substance operations.
Prior experience of single use systems (bioreactors, single use mixers) would be an advantage.
Ability to present and defend technical aspects of manufacturing operations.
Self-motivated, detail orientated enjoys the fast pace environment of start-up.