Job Title: Senior Analytical Development Chemist
Location: Virginia, Brisbane, onsite
Reports To: Analytical Development Lead
You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As an [Experienced Hire Role] , you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human.
The Virginia Development Centre leads the product development process (including formulation and analysis) for Opella's innovation pipeline in ANZ. We collaborate closely with the Brand & Innovation (B&I) and R&D teams to ensure that the new product developments are aligned with the innovation strategy, coordinate with the Project Managers to prioritise time, budget, and resources to meet the project needs, work with the Regulatory & Quality teams to ensure our products are compliant, safe, and stable, and work with the Production team to ensure that the manufacturing process is respected and optimised.
We are seeking an experienced Senior Analytical Development Chemist to join our Analytical Development team at our Virginia site. In this role, you will be responsible for planning, executing, and overseeing analytical development activities, with a strong focus on method development, validation, and stability testing in compliance with TGA, GMP, and ICH Q2 requirements.
You will play a key role in delivering high-quality, stability-indicating analytical methods and producing robust, audit-ready validation documentation, while supporting regulatory submissions and ensuring ongoing product quality.
Key Responsibilities:
- Research, develop, and validate stability-indicating analytical methods using techniques including:
- HPLC / UPLC (UHPLC) with various detectors, including LC-MS
- Gas Chromatography (GC-FID)
- Dissolution testing
- HPTLC
- ICP-MS
- FTIR
- Lead and author analytical method validation protocols and reports, ensuring compliance with TGA and ICH Q2 requirements (critical requirement).
- Conduct analytical method validation across multiple dosage forms, including:
Raw Materials, Bulk Products, Tablets, Hard Capsules, and Softgel Capsules.
- Execute and oversee stability testing programs, including in-house testing of actives using validated, stability-indicating methods, ensuring Right First Time (RFT) performance.
- Evaluate the suitability and quality of new raw materials.
- Review analytical data and peers’ work to ensure accuracy, precision, and compliance with methods and SOPs.
- Prepare and maintain high-quality technical documentation, including protocols, test methods, validation reports, and investigation reports.
- Investigate and report Out-of-Specification (OOS) and Out-of-Trend (OOT) results; participate in root cause analysis and implement CAPA actions.
- Perform calibration, maintenance, and advanced troubleshooting of analytical instruments.
- Ensure compliance with TGA, GMP, GLP, pharmacopeial requirements, and internal procedures.
- Support regulatory submissions, variations, and responses to TGA queries, and participate in audits as an analytical SME.
- Collaborate cross-functionally to troubleshoot analytical and technical challenges.
About You:
- Postgraduate qualification (Master’s or PhD) in Chemistry or related discipline, or equivalent industry experience demonstrating an advanced level of analytical development expertise.
- Minimum 8+ years’ experience in analytical development within nutraceutical, pharmaceutical, or related industries.
- Strong, demonstrated experience in method development and validation, including authoring validation reports (essential).Hands-on expertise in analytical instrumentation: HPLC, UPLC, GC, LC-MS, ICP-MS, FTIR.
- Experience working in a TGA-regulated and GMP environment.
- Strong understanding of ICH Q2 validation principles and data integrity.
- Strong teamwork within an analytical development environment, including effective collaboration with peers on method development, data review, troubleshooting, and validation activities.
- Proven ability to troubleshoot complex analytical issues, particularly in herbals and multi-actives formulations.
This is more than the next step in your career, it’s a chance to lead change and help reinvent self-care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella.
Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.
Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.
At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan , Doliprane ,Dulcolax, Enterogermina , Essentiale and Mucosolvan .
As a globally certified B Corp company, we are active players in the journey towards healthier people and planet . Find out more about our mission at www.opella.com .
