CY Partners have an exciting opportunity for a highly experienced Study Director Immunoassays to join a rapidly growing CRO based in Australia. The main responsibilities include performing Study Director / Principal Investigator functions for immunoassay-based validations and analysis.

Role Responsibilities:

• 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

Skills and Qualifications:

• BSc, MSc or PhD in a Life Science discipline
• 5-10 years’ experience in a regulated GLP Bioanalysis Immunoassay laboratory, including:
  • PK, PD, ADA studies; ligand binding assays; clinical biomarker studies; assay development
• CRO experience across the European and/or North American markets
• Proven experience as Study Director / Principal Investigator
• 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 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 at CY Partners (07851 246 846 / [email protected]).

Due to the current pandemic and climate, start dates for this role will be decided following all Government guidelines.

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