Materials Management Scientist/Snr Scientist - Technical Services/Manufacturing Sciences
Our biopharma client, based in Limerick, is a global healthcare leader dedicated to discovering and delivering life-changing medicines to improve the lives of people around the world. With a strong focus on innovation and collaboration, they aim to enhance the understanding and management of diseases while contributing positively to communities through philanthropy and volunteerism. Join a team where people come first, and exceptional work makes a real difference.
To support the continuous growth of their monoclonal pipeline of products, our biopharma client has invested in a new facility in Limerick. This exciting opportunity enables talented individuals to contribute to establishing this facility as a reliable supplier of innovative medicines, making a difference in people’s lives.
If you are seeking a challenging, rewarding career and meet the requirements below, we would love to consider you for this role.
Key Responsibilities
* Understand the scientific principles required for manufacturing intermediates and bulk drug substances, especially regarding the impact of material attributes on process chemistry and product protection.
* Serve as a scientific liaison between the Materials/Procurement Process Team and Process Scientists.
* Establish and own the site’s extractables and leachable program to create documented risk assessments to enable manufacturing start-up.
* Work with the Materials/Procurement Process Team to:
o Assess materials and supplier risks.
o Audit suppliers.
o Assess and address the impact of supplier changes (drawing input from affected flow(s) scientific SMEs).
o Develop robust control strategies to manage supplier/material risks.
* Prepare, review, approve, and provide technical support for relevant technical documents, including change controls, deviation investigations, plant trial protocols, summary reports, procedures, and technical reports.
* Lead and/or coordinate materials investigations and changes.
* Collaborate with site and global resources to support materials-related laboratory studies.
* Own (or provide input to) materials components of Annual Product Reviews, Management System Reviews, etc.
* Work with manufacturing Process Team counterparts to assess/investigate materials issues and implement materials changes.
Attributes for the Role
* Demonstrated technical capability with high productivity.
* Proven track record of curiosity and learning agility.
* Self-starter with high initiative and a data-driven approach to problem-solving.
* Strong interpersonal skills.
* Strong verbal and written communication skills.
* Adaptability and flexibility to work in different environments and teams.
* Ability to participate in and facilitate decision-making processes.
* Proficient in English.
Educational Requirements
* Honours Degree Qualified BSc, MSc, or PhD degree in biotechnology, biochemistry, chemistry, or a similar discipline.
* Minimum of 5 years' experience working in a GMP or GLP manufacturing environment and with external vendors.
Work Environment
* Occasional travel will be necessary to support supplier visits and audits.
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