Requisition ID: 41898
- Competent in liquid and solid state characterisation of drug product, provide technical support and development to team in these key areas;
- Competent in protein science – protein structure, function, aggregation, degradation - Perform characterisation analysis of proteins;
- Manufacturing Support – product impact to support batch release;
- Experience one or more of the following – Lyophilisation, Formulation, Filtration, Sterile Filling, Technology Transfer, Scale Up, QbD, PAT;
- Support the day to day running of the small scale development laboratory;
- Write and maintain work instructions associated with the laboratory;
- Lead and Support the execution of laboratory studies;
- Maintain Vendor Management Inventory (VMI);
- Strong team player, communicator, excellent presentation and technical writing skills.
- Strong understanding of biopharmaceuticals, protein science (structure, function, degradation), stability;
- Has experience with protein characterisation techniques such as CD, FTIR, DSC, Fluorescence Spectroscopy;
- Liquid and solid state characterisation of drug product, provide technical support and development to team in some of the following these key techniques – Rheometry, XRD, mDSC, TGA, BET, DVS, Karl Fisher;
- Has direct observational experience of full-scale manufacturing processes and associated key analytical techniques;
- Direct experience in day to day laboratory management including Safety, VMI, Equipment management etc.;
- Project Management experience; Product/Scientific Risk Assessments;
- Technology Transfer & Scale up experience;
- Knowledgeable on the fill finish manufacturing processes for the product and the interactions between product and process that impact CQAs and long term stability;
- Has demonstrated understanding and application of relevant Compendial and Pharmacopeial standards to their specification of interest;
- Can review on-going product data (e.g. stability trends, Development studies);
- Understanding of ICH Guidelines Q5, 8, 9, 10; Quality by Design (QbD); Pharmaceutical Development, Product Comparability;
- Can interpret results, trends, investigations, can troubleshoot method and equipment issues, working logically and systematically to resolve problem;
- Excellent Communication and Presentation skills;
- Stakeholder management, networking (internal and external);
- Strong demonstrated leadership skills, a self-manager.
MSc or equivalent.
At least 1-3 years’ experience in a relevant pharmaceutical or biopharmaceutical role.