Quality Control Manager

KE Select - Scientific & Medical Recruitment Specialists; Brisbane; Presencial; AUD 180.000 - 240.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive remuneration

Descripción de la vacante

KE Select - Scientific & Medical Recruitment Specialists is partnering with a fast-growing Australian biotechnology manufacturer to appoint a Head of Quality Control. You will lead the Analytical Sciences and QC laboratory, overseeing method development, validation, transfer and GMP implementation while driving continuous improvements.

The role requires a PhD or equivalent, extensive GMP/pharma/biotech experience, and a proven track record in building capable analytical teams.

Formación

• PhD or equivalent in Analytical Chemistry, Molecular Biology, Biochemistry or related discipline.
• Extensive GMP pharmaceutical/biologics/biotech experience.
• Strong background in analytical method validation, transfer, lifecycle management.
• Expertise in chromatography and molecular biology assays.
• Proven leadership of scientific teams and laboratory operations.
• Solid GMP compliance and data integrity awareness.

Responsabilidades

• Lead analytical method development, qualification, validation, transfer and lifecycle management.
• Provide technical leadership across UHPLC/HPLC, qPCR, RT-qPCR, ddPCR, capillary electrophoresis and related techniques.
• Drive establishment of new analytical capabilities across development and GMP labs.
• Lead investigations, CAPAs, risk assessments and data integrity initiatives.
• Serve as analytical SME during audits, inspections and regulatory interactions.
• Build, mentor and develop a high-performing team of analytical scientists.
• Collaborate with QA, Manufacturing, R&D, Regulatory and external stakeholders.

Conocimientos

Analytical method validation

Method transfer

Leadership

GMP

Molecular biology assays

Chromatography

Data integrity

Educación

PhD or equivalent in Analytical Chemistry, Molecular Biology, Biochemistry

Descripción del empleo

Join an innovative Australian biotechnology organisation advancing next-generation therapeutics through cutting-edge manufacturing and analytical science. This is a rare leadership opportunity to establish and grow a high-performing Quality Control function while shaping the analytical strategy that supports product development and GMP manufacturing.

About the Company

Our client is a fast-growing biotechnology manufacturer focused on delivering advanced therapeutic products through world‑class science, quality, and innovation. With significant investment in capability expansion, they are building a team of highly experienced scientists and technical leaders to support their next stage of growth.

About the Role

As Head of Quality Control, you will provide strategic and operational leadership for the Analytical Sciences and QC laboratory. You will oversee the complete analytical method lifecycle, from development and validation through to GMP implementation, routine testing, and continuous improvement.

Key responsibilities include:

• Leading analytical method development, qualification, validation, transfer, and lifecycle management
• Providing technical leadership across UHPLC/HPLC, qPCR, RT-qPCR, ddPCR, capillary electrophoresis, and related molecular techniques
• Driving the establishment of new analytical capabilities across both development and GMP laboratories
• Leading investigations, CAPAs, risk assessments, and data integrity initiatives
• Acting as the analytical SME during audits, inspections, and regulatory interactions
• Building, mentoring, and developing a high-performing team of analytical scientists
• Collaborating closely with QA, Manufacturing, R&D, Regulatory Affairs, and external stakeholders

About You

• PhD or equivalent in Analytical Chemistry, Molecular Biology, Biochemistry, or a related discipline
• Extensive experience within GMP pharmaceutical, biologics, vaccine, or biotechnology environments
• Strong background in analytical method validation, transfer, and lifecycle management
• Expertise in chromatography, molecular biology assays, and advanced analytical technologies
• Demonstrated success leading scientific teams and laboratory operations
• Deep understanding of GMP, data integrity, and regulatory expectations
• A technically strong leader who enjoys building capability and driving continuous improvement

What's on Offer

• Opportunity to lead and shape a critical function within a growing biotechnology organisation
• Influence analytical strategy and capability development from the ground up
• Work with advanced technologies supporting innovative therapeutic products
• Lead a team of highly skilled scientists in a collaborative and mission-driven environment

Applicants must have unrestricted Australian working rights. Visa sponsorship is not available for this position.