Quality , Science, Pharmaceutical & Food
Tech Specialist – Cell Culture
- Dublin North
PE Global are currently recruiting a Technical Specialist on behalf of our client based in North Dublin:
12 Month initial contract
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.
- Materials: Acting as technical SME to support the selection and introduction of critical raw materials and single use components
- Providing technical leadership for material/component related issues, complaints, and investigations
- Identifying opportunities to simplify existing manufacturing processes
- Liaising with Vendors to ensure they conduct adequate investigations and implement appropriate corrective actions when issues are identified
- Providing significant technical depth to support troubleshooting efforts and deviation investigations in conjunction with Technical Services, Operations, Engineering and Quality
- To author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents
- 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
- Minimum 2+ years’ experience in Technical Services / Process Development / Manufacturing 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
- 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
- Knowledge or experience of start-up or systems would be ideal
- Detail orientated
- Technical writing competency
- Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
- Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV to email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***