Technical Services Specialist
We are recruiting for a Technical Services Specialist on behalf of a leading pharmaceutical company based in Dublin. This is an initial 12 month contract role.
Description:
The Technical Services Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS).
Responsibilities:
* To provide process expertise in Downstream purification process: buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.
* To author and review process technical documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents.
* To lead or support the continuous process verification program at ADMF.
* To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements.
* To support the changes in raw materials and consumables.
* 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.
* To identify and implement process improvements, e.g. yield, cycle time reduction.
* To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
* To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution.
* To lead any key process changes using change control system.
* To adhere to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
* To ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations.
* To author and review common technical document (CTD) sections and reports for regulatory agency submissions.
* To serve as a subject-matter expert (SME) on downstream purification process and support during regulatory agency inspections.
Requirements:
* BSc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
* Experience of authoring CMC sections of regulatory submissions.
* Minimum 3+ years experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.
* Technical and operational knowledge of multiple unit operations in cell culture processing.
* Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
* Experience of Technology Transfer activities is advantageous.
* Knowledge or experience of start-up or systems would be ideal.