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Materials Management Scientist - County Cork
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Materials Management Scientist - County Cork.
In this role you will be an active member of the Materials Management Process Team that provides technical support for manufacturing, with an emphasis on the scientific aspects of materials (raw materials, consumables) used in production. This position will interact with Engineering, Manufacturing, Quality Assurance, Quality Control, Procurement, Regulatory departments, other sites and external suppliers. Knowledge of cell culture, purification and the support systems used in the manufacture of biotech products is required.
Understand the scientific principles required for manufacturing intermediates and bulk drug substances, especially the impact of material attributes on process chemistry & product protection.
Provide technical support and expertise for the qualification and implementation of new raw materials and consumables.
Work effectively and efficiently in a cross-functional team with Quality Control, Quality Assurance, Operations Planning, and Procurement to ensure reliable supply of raw materials and consumables.
Lead technical evaluations of second sources of key raw materials and consumables to firm up supply chain.
Own extractable and leachables risk assessments as needed to support commercial manufacturing.
Anticipate and resolve complex problems. Drive solutions that impact the site.
Prepare, review, approve and provide technical support for preparation of relevant technical documents such as: change controls, deviation investigations, plant trial protocols and summary reports, procedures, and technical reports.
Provide technical support during the evaluation of supplier change notifications (SCN).
Own (or provide input to) materials components of Annual Product Reviews, Management System Reviews, etc.
Work with manufacturing Process Team counterparts to assess/investigate material issues and implement materials changes.
PhD in Biochemistry, Cell Biology, Biotechnology, Microbiology, Analytical Science, Biochemical Engineering, or related discipline.
MSc with relevant experience (>2 years’ experience within the biopharmaceutical industry) will also be considered.
Excellent self-management and organisational skills; able to manage a varied workload, set/ respond to personal and team priorities and adjust as needed.
Demonstrated ability to proactively identify issues and either resolve or escalate to the appropriate level for resolution.
Strong collaborative skills with an ability to work effectively in a team environment.
Demonstrated high learning agility and flexibility & ability to deal with ambiguity.
Deep technical interest and understanding in the field of materials management science.
Demonstrated ability to participate in and facilitate decision-making.
Demonstrated strong verbal and written communication skills.
Strong analytical and problem-solving skills.
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