Study Director - Immunoassay

Agilex Biolabs; Adelaide; On-site; AUD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive salary

Professional development

Job summary

Agilex Biolabs in Adelaide is seeking a Study Director for Immunoassay to oversee and direct bioanalytical studies, ensuring regulatory compliance and timely delivery. The role requires leadership of a skilled team, review of protocols, and effective collaboration with clients and partners to achieve project milestones.

You will mentor staff, maintain high-quality data, and ensure adherence to GLP and GCP standards while supporting drug development from discovery through clinical trials.

Qualifications

• A degree in biology, biochemistry, or related field.
• At least 5 years in a bioanalytical laboratory setting with immunoassays.
• Strong understanding of regulatory guidelines and quality assurance processes.
• Excellent communication skills and ability to work collaboratively in a team.

Responsibilities

• Manage and direct immunoassay studies, ensuring regulatory compliance.
• Collaborate with cross-functional teams to deliver high-quality results within project timelines.
• Review and approve study protocols, reports, and other documentation.
• Mentor and guide junior staff in immunoassay techniques and best practices.

Skills

Immunoassay techniques

GLP/GCP knowledge

Project management

Study design

Data analysis software

Education

Bachelor's degree in biology/biochemistry or related field

Tools

LIMS

Job description

Study Director - Immunoassay at Agilex Biolabs

As a Study Director for Immunoassay at Agilex Biolabs, you will oversee and manage bioanalytical studies, ensuring they meet regulatory standards and client expectations. This position requires a strong background in immunoassay methodologies and the ability to lead a team in a fast-paced laboratory environment. You will play a crucial role in supporting drug development from initial discovery through clinical trials.

Key facts

• Location: Adelaide CBD, Adelaide
• Engagement: Permanent
• Team: Study Management

What you'll do

• Manage and direct immunoassay studies, ensuring compliance with regulatory requirements.
• Collaborate with cross-functional teams to deliver high-quality results within project timelines.
• Review and approve study protocols, reports, and other documentation.
• Mentor and guide junior staff in the execution of immunoassay techniques and best practices.

Requirements

• A degree in a relevant scientific field such as biology, biochemistry, or a related discipline.
• At least 5 years of experience in a bioanalytical laboratory setting, with a focus on immunoassays.
• Strong understanding of regulatory guidelines and quality assurance processes.
• Excellent communication skills and the ability to work collaboratively in a team environment.

Nice to have

• Experience with cell and gene therapy applications.
• Familiarity with data analysis software and laboratory information management systems (LIMS).

Skills & tools

• Proficiency in various immunoassay techniques, including ELISA, MSD, and other related methodologies.
• Knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) standards.
• Experience with project management and study design.

Practical notes

• Applicants must have the right to work in Australia.
• Agilex Biolabs offers competitive salary packages and benefits, including opportunities for professional development.