Overview
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..
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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
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