Senior Scientist

2 weeks ago

Limerick, Limerick, Ireland Cpl Healthcare Full time
Senior Scientist

Materials Management- 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.

Materials Management Scientist/Snr Scientist - Technical Services/Manufacturing Sciences

The Materials Management Scientist will provide technical oversight of raw materials and consumables used during the manufacture of monoclonal antibodies and fusion proteins to ensure the reliable supply of materials with safety first and quality always. The role includes qualification, implementation, continuous improvement, investigation support, and technology transfer. This position will work closely with Engineering, Operations, Quality Assurance, Quality Control, Procurement, and Regulatory departments both locally and globally, as well as with external suppliers. Knowledge of cell culture, purification, and the support systems used in the manufacture of biotech products is essential.

Key Responsibilities

1. 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.
2. Serve as a scientific liaison between the Materials/Procurement Process Team and Process Scientists.
3. Establish and own the site's extractables and leachable program to create documented risk assessments to enable manufacturing start-up.
4. Work with the Materials/Procurement Process Team to:

1. Assess materials and supplier risks.
2. Audit suppliers.
3. Assess and address the impact of supplier changes (drawing input from affected flow(s) scientific SMEs).
4. Develop robust control strategies to manage supplier/material risks.

6. 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.
7. Lead and/or coordinate materials investigations and changes.
8. Collaborate with site and global resources to support materials-related laboratory studies.
9. Own (or provide input to) materials components of Annual Product Reviews, Management System Reviews, etc.
10. Work with manufacturing Process Team counterparts to assess/investigate materials issues and implement materials changes.

Attributes for the Role

1. Demonstrated technical capability with high productivity.
2. Proven track record of curiosity and learning agility.
3. Self-starter with high initiative and a data-driven approach to problem-solving.
4. Strong interpersonal skills.
5. Strong verbal and written communication skills.
6. Adaptability and flexibility to work in different environments and teams.
7. Ability to participate in and facilitate decision-making processes.
8. Proficient in English.

Educational Requirements

1. Honours Degree Qualified BSc, MSc, or PhD degree in biotechnology, biochemistry, chemistry, or a similar discipline.
2. Minimum of 5 years' experience working in a GMP or GLP manufacturing environment and with external vendors.

Work Environment

1. Occasional travel will be necessary to support supplier visits and audits.

Our biopharma client does not discriminate on the basis of age, race, colour, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status. You must have the right to work in Ireland.

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