Job Description:
The Technical Services Specialist has responsibility for providing technical support to the drug product manufacture at the Athlone manufacturing facility.
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.
Key Responsibilities:
* Provide significant technical expertise to support all aspects of the drug product manufacturing at the Athlone Fil Finish 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
* Author and review process supporting documentation, process descriptions, gap assessments, technical protocols and reports, process validation documentation, strategy documents
* Support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications
* 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
* Generate documentation reports for technical studies
* Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits
Requirements:
* Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field
* Experience in technical services support in the drug product manufacture and/or process development and/or manufacturing support
* Comprehensive understanding of c GMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices
* Prior experience in use of single use systems (single use mixers, manifolds) would be an advantage