QC Manager - Analytical Sciences

KE Select; City of Brisbane; On-site; AUD 180,000 - 280,000; Full time

Job summary

KE Select is partnering with an Australian biotechnology organisation to appoint a Head of Quality Control responsible for strategic leadership of Analytical Sciences and the QC laboratory, overseeing method lifecycle from development to GMP implementation and routine testing.

The role reports to senior leadership, builds a high-performing team, and collaborates with QA, Manufacturing, R&D, and Regulatory Affairs to shape the analytical strategy for next-generation therapeutics.

Qualifications

• PhD in Analytical Chemistry, Molecular Biology, Biochemistry or related field.
• Extensive GMP pharma/biotech experience.
• Proven track record in analytical method validation and lifecycle management.
• Expertise with chromatography and molecular assays.
• Strong leadership and team-building capabilities.
• Solid understanding of data integrity and regulatory expectations.

Responsibilities

• Lead analytical method development, qualification, validation, and transfer.
• Oversee QC laboratories and lifecycle management.
• Drive new analytical capabilities for development and GMP labs.
• Lead investigations, CAPAs, and risk assessments.
• Represent analytics during audits and regulatory reviews.
• Mentor and develop a high-performing analytical team.
• Collaborate with QA, Manufacturing, R&D, and Regulatory.

Skills

Leadership

GMP knowledge

Analytical method validation

UHPLC/HPLC

qPCR/RT-qPCR/ddPCR

Molecular biology assays

Data integrity

Regulatory inspections

Education

PhD in Analytical Chemistry

Tools

UHPLC/HPLC

qPCR

RT-qPCR

ddPCR

Capillary electrophoresis

Job description

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.

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.