Study Director – Immunoassay

Study Director – Immunoassay (Regulated Bioanalysis)

Location: South Australia, on site

Position Type: Full-Time, Permanent

Relocation: International relocation support available for qualified global applicants

About the Company

Our client is Australia’s largest and most technologically advanced regulated laboratory. They have been a recognised global leader in providing large and small molecule drug development support, recently expanding into the cutting-edge cell & gene therapy space.

Operating from world-class, FDA-inspected, and OECD GLP-recognised facilities, they support biopharmaceutical and pharmaceutical clients across the APAC region, USA, and Europe to accelerate vital drug development programs.

Position Overview

We are seeking an experienced Study Director – Immunoassay (IA) to take autonomous ownership of immunoassay-based validations and analyses. In this high-impact role, you will ensure the scientific integrity and regulatory compliance of GLP studies while acting as the primary scientific partner to global pharmaceutical and CRO clients.

Additionally, you will provide critical line management, mentoring, and training to internal support functions (Study Support Officers and Study Co-ordinators) to drive operational excellence.

Key Responsibilities

• Study Leadership: Function as the primary Study Director or Principal Investigator for multiple GLP studies autonomously, maintaining overarching accountability for study timelines and regulatory compliance.
• Client & Stakeholder Management: Communicate effectively with external clients and CROs regarding project status, timelines, and high-level scientific queries or troubleshooting.
• Team Mentoring: Provide direct line management, training, and mentorship to the immunoassay support team.
• Cross-Functional Collaboration: Partner closely with internal R&D, Operations, Lead Analysts, and Quality Assurance (QA) teams to ensure smooth method transitions, resolve technical challenges, and keep projects moving efficiently.
• Process Improvement: Author and review SOPs, contribute to continuous improvement initiatives, and ensure the team remains fully aligned with evolving global regulatory expectations.

Required Qualifications & Experience

• Education: Ordinary degree in Life Sciences or a related scientific discipline.
• Industry Experience: At least 5 years of experience in regulated bioanalysis, ideally within a pharmaceutical or CRO environment.
• Role Experience: Direct experience working as a Study Director managing projects within a regulated GLP environment.
• Technical Expertise: Proven hands-on experience with immunoassay development and deep familiarity with Laboratory Information Management Systems (LIMS), ideally Watson LIMS.
• Leadership Skills: Strong capability or direct experience in line management, mentoring, and team training.
• Soft Skills: Outstanding problem-solving skills, scientific data interpretation, and high-level written and verbal communication skills.

What’s on Offer

• The chance to work at the forefront of global drug development and cell/gene therapy.
• A supportive, positive, and dynamic team culture built on trust and reliability.
• State-of-the-art laboratory infrastructure and equipment.

Reach out now!