Technical Services Specialist (Upstream and Downstream)

Team Horizon is seeking a Technical Services Specialist (Upstream and Downstream) for our client based in Dublin.

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.


• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• Excellent contracting rates on offer.

What you will be doing:

• To provide process expertise in one, or both of the following disciplines:


•  Upstream (Cell culture focus) to include media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification.


• Downstream to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration, viral reduction filtration and viral inactivation technologies and DS formulation, bulk fill and storage.


• To author and review process transfer documentation, gap assessments, technical protocols and reports, clinical manufacturing documentation, process validation documentation, strategy documents etc...


• To identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to oversee the design and execution of studies.


• 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 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.


• May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution and provide on-call support to manufacturing.


• To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution.Lead any key process changes using change control system.


• 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 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 technology transfer and process support during regulatory agency inspections.

What you need to apply:

• 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 and or downstream purification processing


• Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing


• Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings


• Ability to present and defend technical and scientific approaches in both written and verbal form


• Ability to drive for results independently and adapt to rapidly changing priorities


• Experience of Technology Transfer activities is advantageous


• Experience of clinical manufacturing activities is advantageous


• Knowledge or experience of start-up or systems would be ideal


• Technical writing competency  


• B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering


• M.Sc. 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