Senior Scientist
Materials Management - Technical Services/Manufacturing Sciences
Our biopharma client is a global healthcare leader dedicated to discovering and delivering life-changing medicines. With a focus on innovation and collaboration, they aim to enhance the understanding and management of diseases while contributing positively to communities through philanthropy and volunteerism.
To support the continuous growth of their monoclonal pipeline of products, our biopharma client has invested in a new facility. This exciting opportunity enables talented individuals to contribute to establishing this facility as a reliable supplier of innovative medicines.
The Materials Management Scientist will provide technical oversight of raw materials and consumables used during the manufacture of monoclonal antibodies and fusion proteins. The role includes qualification, implementation, continuous improvement, investigation support, and technology transfer.
Key Responsibilities
* Understand the scientific principles required for manufacturing intermediates and bulk drug substances.
* Serve as a scientific liaison between the Materials/Procurement Process Team and Process Scientists.
* Establish and own the site's extractables and leachable program.
* Work with the Materials/Procurement Process Team to assess materials and supplier risks, audit suppliers, and develop robust control strategies.
* Prepare, review, approve, and provide technical support for relevant technical documents.
* Lead and/or coordinate materials investigations and 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.
* Adaptability and flexibility to work in different environments and teams.
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 may be necessary to support supplier visits and audits.