Job Description
Our client, a Biotech company based in Munster region, now seek a MSAT Materials who will work as part of the Materials Management Process Team in providing technical support for biotech manufacturing with an emphasis on the scientific aspects of materials (raw materials, consumables) used in production.
The successful candidate will exercise knowledge of scientific principles required for manufacturing intermediates and bulk drug substances, especially the impact of material attributes on process chemistry & product protection.
This hire will work in collaboration with Engineering, Manufacturing, Quality Assurance, Quality Control, Procurement, Regulatory departments, other company sites and external suppliers, to ensure reliable supply of raw materials and consumables.
The ideal candidate will have knowledge of cell culture, purification and the support systems used in the manufacture of biotech products.
Key Responsibilities:
Provide technical support and expertise for the qualification and implementation of new 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 (both within and external to MSAT as required) 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.
Requirements:
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 organizational skills; able to manage a varied workload, set/ respond to personal and team priorities and adjust as needed.
Strong collaborative skills with an ability to work effectively in a team environment.
Proven high learning agility and flexibility & ability to deal with ambiguity.
Deep technical interest and understanding in the field of materials management science.
Strong verbal and written communication skills.
Strong analytical and problem-solving skills.
For further details, please contact Larry on +353 (0) 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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