We have a fantastic opportunity for an experienced Senior Method Development Scientist (Immunoassays) at a leading CRO based in Australia. The main responsibilities include bioanalytical method development and transfer for ligand-binding assays and supporting the immunoassay laboratory team.

Key Responsibilities and Duties:

• Responsible for bioanalytical method development, transfer and pre-validation (NCEs, Biosimilars, Anti-drug antibodies etc) and ensure guidelines (FDA, EMA) are met in a timely and cost-effective manner
• Lead troubleshooting and technical investigations with support from Manager and/or senior staff members
• Communicate with clients and internal bioanalytical regulatory groups
• Write and Review Analytical Laboratory Methods and Company SOPs; contribute to Continuous Improvement
• Support and manage R&D projects and escalate any resourcing concerns, as well as review new projects as required
• Ensure adherence to OECD GLP regulations as well as Company Guidelines, Quality Systems and SOPs

Ideal Skills and Qualifications:

• Degree qualified, or equivalent, in a relevant scientific discipline
• Minimum 4 years’ experience in a regulated analytical/bioanalytical laboratory (CRO)
• Minimum 2 years’ experience in analytical method development (ligand-binding assays)
• Proven experience delivering tasks on time to a high level of accuracy
• Proven experience in communicating with clients on high level science issues as well as remaining strictly confidential
• Ability to analyse problems, formulate effective solutions and interpret scientific data

The company is a Contract Research Organisation specialising in providing drug development services for the pharmaceutical and biotechnology industries. You will be working in their state-of-the-art facilities based in Adelaide, Australia with Visa and relocation support provided.

If you are interested or have any questions about this role, feel free to contact Harriet at CY Partners.

Tagged as: Bioanalytical, CRO, Immunoassays, Ligand-binding Assays, Method Development, Method Validation, SOPs