Team Lead QC Chemistry Stability and AS&T
Melbourne, Australia | full time | Job ID: 10523
The Team Lead QC Chemistry/Stability/AS&T is responsible for establishing and leading QC Chemistry, Analytical Science & Technology, and Stability functions for a new clinical manufacturing facility in Australia. This role is pivotal in building the QC Chemistry laboratory from the ground up - developing infrastructure, implementing systems, recruiting and training staff, and ensuring full compliance with TGA and global GMP standards. As a hands-on leader, the successful candidate will oversee day-to-day laboratory operations, whilst actively contributing to analytical testing, method development/qualification/implementation, and stability program activities.
Your main responsibilities are:
- Support the qualification and operational readiness of the QC Chemistry Laboratory, including procurement, installation, and qualification of analytical instruments.
- Develop and implement SOPs, workflows, and quality systems aligned with TGA and PIC/S guidelines.
- Oversee and participate in method transfer, development, and validation activities in accordance with ICH Q2(R2), Q14, and relevant compendial requirements.
- Manage the site stability program, including protocol creation, stability chamber qualification, sample management, trending, and reporting.
- Perform and/or review analytical testing to support batch release, stability studies, and raw material testing.
- Provide technical leadership and subject matter expertise during OOT/OOS investigations, regulatory inspections, and stability trends.
- Recruit, train, and mentor QC Chemistry/Stability/AS&T staff to build a high-performing team while fostering a culture of safety, quality, and continuous improvement in a dynamic start-up environment.
- Lead and contribute to QC Chemistry raw material, product release, and stability testing, as well as AS&T activities, including method validation, verification, and transfer for clinical products.
- Ensure data integrity and compliance for computerized systems (e.g., LIMS, Empower) per TGA expectations.
- Maintain adherence to global SOPs and local regulatory requirements (TGA, PIC/S), and ensure inspection readiness at all times.
- Lead investigations for deviations, OOS, and stability trends, and implement CAPAs.
- Partner with QA, MS&T, SCM, and Manufacturing to support technology transfers, clinical batch release, and contribute to site quality council and continuous improvement initiatives.
What you have to offer:
- Bachelor’s degree (or higher) in Chemistry, Pharmaceutical Sciences, Biochemistry or related discipline.
- Minimum 10 years of QC experience in GMP aseptic manufacturing, including start-up or greenfield projects. (Experience in building QC chemistry and stability labs from ground up, including equipment qualification and SOP development./Ability to work in an evolving environment with limited structure and rapidly changing priorities/ Familiarity with clinical trial product requirements and early-phase manufacturing challenges.
- Strong knowledge of Australian GMP guidelines, TGA requirements, and PIC/S standards.
- Demonstrated expertise in method development, transfer, qualification and validation.
- Extensive experience in data integrity (ALCOA+), deviation management, OOS/OOT investigations, CAPA and change control systems.
- Direct experience in supporting regulatory inspections.
- Proven ability to coach and develop high-performing QC teams, including analytical chemists, and stability. AS&T capabilities.
- Proven ability to lead teams and manage complex QC Chemistry operations in a fast-paced environment.
- Excellent verbal and written skills.
What we do with the BioNTainers:
We want to improve healthcare by making our innovations accessible worldwide. Therefore, we developed the first modular mRNA-manufacturing facilities based on a container solution called “BioNTainers”. Help us build a regional manufacturing network in Africa & Australia: With the region and for the region. As a part of the local team, driving the establishment of the regional end-to-end mRNA manufacturing solutions.
Benefits for you:
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Click here to find out more about what we do, the careers we offer ans also the benefits we provide. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.