Biologics Downstream Technical Specialist
Our client a leading pharmaceutical device company located in Cork requires Biologics Downstream Technical Specialist.
- This role will report to the Technology Lead, Biologics DS IPT.
- The Downstream Tech Spec will demonstrate a high level of innovation, enthusiasm and drive to deliver technical excellence for characterisation and optimisation of biomanufacturing processes and will be accountable for providing scientific and technical support to the Purification operations team for effective and efficient running of all operations activities to a defined daily, weekly and monthly schedule as agreed with our customers.
- This requires a flexible, collaborative, and coaching style and will require a substantial amount of his/her time within the IPT process, engaging and communicating with all IPT members.
- Provision of Technical Support of the large scale Drug Substance Manufacturing process including process performance monitoring, troubleshooting, process optimisation.
- Provide Process Design Support during the construction and commissioning of unit operations in Purification facility and collaborating seamlessly with counterpart in the upstream area.
- Optimization of unit operations large scale to drive continuous improvement, process optimization in the Purification processes.
- Lead and participation in cross-functional problem solving teams for troubleshooting, and investigations within Biologics, Sterile and Quality in Cork in addition to other Sites as required.
- Prepare analytical comparability plans in accordance with ICH Q5E to evaluate the comparability of pre- and post-change material.
- Preparation, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
- 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
- Active pursuit of development opportunities to increase the skill set and experience within the group through continuous education, job rotation, cross-functional training, Lean Six Sigma, etc
- Collaboration with internal and external partners
- Actively Participate in a culture of Continuous Improvement and process optimisation by deploying Six Sigma tools.
- Providing coaching and support to the Operations team to build their knowledge of process science.
- Demonstrated ability to fully realize improvement initiatives.
- Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
- More than 2 years' experience in similar Downstream Technical Support role in Microbial or Cell culture and purification manufacturing
- MSc Degree in Biochemistry (PhD Preferable) or suitable equivalent.
- Six Sigma Green Belt certified.
- Evidence of Continuous Professional Development and cross-skilling
- Excellent interpersonal skills.
- Customer focus.
- Excellent communication skills both written and verbally.
- Good problem solving skills.
- Results and performance driven.
- Adaptive and flexible.
For further information on this Biologics Downstream Technical Specialist role in Cork please contact Caroline Kingston on 0868395531 firstname.lastname@example.org
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