We have an exciting opportunity for a highly experienced Study Director within Immunoassay Development (IA) at a leading CRO based in Australia. The main responsibilities include performing Study Director / Principal Investigator functions for immunoassay-based validations and analysis.

Key Responsibilities and Duties:

• Manage studies as well as company and external stakeholders to ensure timelines are achieved
• Communicate with internal stakeholders to ensure project progression
• Ensure compliance to all regulatory standards
• Troubleshoot scientific issues by liaising with R&D, operations, management and Lead Analysts
• Update and review Analytical Laboratory Methods (ALMs)
• Develop, transfer and validate assays and analytical methods to support drug analysis

Ideal Skills and Qualifications:

• Degree qualified in a Life Science discipline; or equivalent
• 5-10 years’ experience in a regulated bioanalytical and Immunoassay Development laboratory
• Proven GLP and CRO experience; required
• Minimum 2 years’ experience as Study Director/Principal Investigator; required
• Proven ability to review SOPs and ALMs
• Previous experience in communicating with clients on high level science issues as well as remaining strictly confidential
• Experience with LIMS/Watson
• Ability to work effectively both in isolation and as part of a team
• Ability to analyse problems, formulate effective solutions and coordinate tasks simultaneously

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 (07851 246 846) at CY Partners.

Tagged as: ALMs, Assay Development, Bio-analytical, GLP, Management, Method Validation, SOPs, Study Sample Analysis