CY Partners are working with a rapidly expanding bioanalytical services CRO in Australia, who are now looking for experienced Study Directors within Immunobiology to join their growing teams. The main responsibilities include performing Study Director / Principal Investigator functions for immunobiology- and immunoassay-based validations and analysis.

Key Responsibilities and Duties:

• Develop and validate flow cytometry assays, cell based neutralising assays and biomarker assessments within a regulatory environment
• Design flow cytometry assays to support clinical studies
• Manage high volume of studies autonomously as well as company and external stakeholders to ensure timelines are achieved
• Responsible for a large client base
• Communicate with internal stakeholders to ensure project progression
• Ensure compliance to all regulatory standards through the review of all runs and validation of study sample analysis
• 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
• Update and maintain SOPs
• Commit to frequent training programs and ensure compliance to Company quality systems

Ideal Skills and Qualifications:

• Degree qualified in a Life Science discipline
• 5-10 years’ experience in a regulated bioanalytical and Immunobiology Development laboratory, including: immunoassay development, cell-based assays, and flow cytometry assay development & validation (essential)
• Proven GLP and CRO experience; essential
• Minimum 5 years’ experience as Study Director / Principal Investigator
• Proven ability to review bioanalytical 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: assay, Assay Development, Bioanalysis, Bioanalytical, Cell based assays, Development, Flow Cytometry, GLP, immunoassay, Immunobiology, Principal Investigator, SOPs, Study Director