Posted on Apr 24, 2021 by Elevate Direct
Downstream Scientist/Engineer - Louth, Ireland
The Downstream Process Scientist/Engineer will provide technical expertise to support of the commercial manufacturing of therapeutic proteins in a mammalian cell culture facility.
The role will ensure on-going optimisation of the Downstream process and provide manufacturing support to ensure the continued manufacture and supply of quality biologic products.
The successful candidate will have the ability to support tech transfer activities for new products, on-going optimisation/continuous improvement of the downstream process, trouble-shooting downstream unit operations and leading major process investigations at the request of the business.
Strong understanding and experience with the modes of operation in downstream processing such as Chromatography, Column pack, Depth Filtration, Virus Filtration, and Inactivation, UFDF and Bulk Drug Substance Filling.
Interface with the project teams to ensure the manufacturing facility will operate as per the user requirements for Chromatography, VI, VF, Int. DF, UFDF and Bulk Fill.
Provide expertise during the design, commissioning, and qualification of the new manufacturing facility at Dundalk through to commercialisation, ensuring all necessary plans are executed and delivered on time.
Serve as a downstream subject matter expert (SME) during the establishment of the commercial process, as well as routine manufacturing.
Subject Matter Expert (SME) for troubleshooting process issues during start-up, tech transfer activities and commercial operations.
Work closely with the extended manufacturing team, ensuring all activities are clearly accounted for and carried out in alignment with plant operations plans.
Identify and implement process improvement projects and cost reduction projects and work cross functionally to prioritise projects/support demands from the Business Unit.
Write APQR and process impact assessments to support investigation closure as applicable.
Implement process CAPA's and performance improvements, conduct investigation trending as required.
Ensure investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented.
Maintain role as Process Guardian'. Responsible for the analysis of routine statistical process control charts and follow-up of trends flagged.
Support regulatory audits.
Optimising re-use of filters and columns gels, sampling plans and consumable usage.
Work to implement a culture of Right First Time by partnering with manufacturing shift teams and provide leadership in the use of Opex principles to optimise technical and business processes.
5+ years exp in the biopharma industry, of which 3+ years exp should be as a downstream
process scientist or process engineer.
Expert knowledge of Downstream Processes and current Good Manufacturing Practices (cGMP).
Strong experience of recipe design, creation and troubleshooting of downstream processes.
Exposure to, and use of, automation systems such as Unicorn and DeltaV (or similar) is desirable.
Demonstrated competencies in Chromatography, Column pack, Depth Filtration, Virus Filtration
and Inactivation, UFDF and Bulk Drug Substance Filling is desirable.
Experience in tech transfer is a key advantage in this role.
Excellent communication skills including computer literacy and ability to work independently.
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