Proclinical is seeking a Quality Control Lead to join our client, a pioneering biologics manufacturer establishing Australia’s first facility dedicated to the production of viral vectors for advanced therapies. Following the successful launch of their state-of-the-art facility, the business is now progressing toward securing its TGA licence and expanding analytical capabilities to support future commercial operations.

As the Quality Control Lead, you will play a pivotal role in developing and implementing QC frameworks, analytical methods, and stability programs with a focus on chemistry within a dynamic GMP environment. This position offers the opportunity to influence laboratory direction, mentor a growing team, and collaborate cross-functionally with Process Development, MS&T, and Production to ensure quality excellence across all operations.

Role Overview

Reporting to the Head of Quality Control and Assurance, the QC Lead (chemistry) will oversee analytical laboratory activities, including method validation, implementation of new equipment, and ongoing development of in-house chemistry testing capabilities and new product development. You will provide hands-on technical support to cross-functional teams and direct teams including responsibilities across documentation, training, and regulatory readiness.

Duration: Permanent, full-time
Start Date: ASAP
Hours: Standard Monday–Friday business hours
Capacity: Fully on-site
Location: Sydney, NSW
Work Rights: Full unrestricted working rights (Citizen or Permanent Resident)
Salary: $110,000 - $130,000 + super (commensurate based on experience)

Role Responsibilities

Lead and guide QC operations for chemistry-based analytical testing (ELISA, HPLC, SDS-PAGE, UV-Vis, conductivity, qPCR).

Oversee method validation, transfer, and implementation of new analytical methods and equipment.

Develop and manage stability programs, analytical frameworks, and related QC documentation in compliance with GMP and data integrity requirements.

Review and approve analytical data, deviations, OOS results, and CAPAs in collaboration with QA.

Provide technical mentorship, training, and support to the QC team while ensuring consistent quality standards.

Liaise with external laboratories for outsourced testing and analytical support.

Collaborate closely with Process Development, MS&T, and Production to support analytical method transfer and technical troubleshooting.

Drive continuous improvement initiatives across QC systems and documentation to strengthen GMP readiness and audit compliance.

Skills and Experience

Tertiary qualification in Chemistry or related scientific discipline (essential).

Minimum 4+ years of experience in Quality Control within a GMP-regulated pharmaceutical, biotech, or CDMO environment.

Proven hands-on expertise with analytical chemistry methods (ELISA, HPLC, UV-Vis, SDS-PAGE, etc.).

Experience in method validation, equipment qualification, and stability program implementation.

Sound understanding of GLP, GMP, TGA, FDA, and/or EU quality requirements.

Excellent documentation, problem-solving, and cross-functional communication skills.

Adaptable, proactive, and confident in making decisions that uphold safety and compliance.

Passion for developing systems, processes, and people within a growing QC function.

How to Apply

If this opportunity aligns with your experience and career aspirations, please click ‘Apply Now’ to submit your application.

For a confidential discussion or to learn more about this role, please contact Pamela Phoumavong at [email protected] or call 0493 093 532.

About Proclinical

Proclinical is a specialist life sciences recruitment agency providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies across the globe.
Proclinical Staffing is an equal opportunity employer.