Study Director

Principal Study Director – Immunoassay (IA)

📍 Australia | Visa Sponsorship | Bioanalysis | GLP | Pharma

Are you an experienced Study Director with a strong background in regulated immunoassay bioanalysis?

CY Partners is partnering with a leading global bioanalytical and toxicology organisation to recruit a Study Director – Immunoassay (IA). This is an exciting opportunity to join a highly respected laboratory business supporting pharmaceutical and biopharmaceutical drug development programs across APAC, Europe, and the USA.

The organisation is recognised for its scientific excellence, advanced bioanalytical capabilities, and strong regulatory reputation, supporting both large and small molecule development as well as emerging cell and gene therapy programs.

The Role

As Study Director, you will lead regulated immunoassay studies from initiation through to completion, ensuring scientific integrity, regulatory compliance, and successful client delivery.

You’ll work closely with operational, QA, and R&D teams while also mentoring junior team members and managing multiple client projects in a fast-paced GLP environment.

Key Responsibilities

✔ Lead GLP immunoassay studies as Study Director / Principal Investigator

✔ Manage study timelines, client expectations, and project delivery

✔ Ensure regulatory compliance and scientific quality standards

✔ Communicate scientific updates and resolve technical challenges with clients and internal teams

✔ Support validation activities and method transitions from R&D

✔ Mentor and support junior scientific staff

✔ Contribute to continuous improvement initiatives and SOP development

About You

🔹 Degree in Life Sciences or related discipline

🔹 Experience in regulated bioanalysis within Pharma or CRO environments

🔹 Experience operating as a Study Director in a regulated setting

🔹 Strong immunoassay development and validation experience

🔹 Experience with GLP studies and client-facing project management

🔹 Knowledge of LIMS systems (Watson preferred)

🔹 Excellent communication and stakeholder management skills

Why Apply?

⭐ Join a globally recognised scientific organisation

⭐ Work with cutting-edge bioanalytical technologies

⭐ Exposure to diverse therapeutic modalities including cell & gene therapy

⭐ Collaborative and high-performing scientific culture

⭐ Excellent opportunity for career progression within a growing global business

📩 Interested? We look forward to receiving your application.

CY Partners is acting as an Employment Agency in relation to this vacancy.