Technical Transfer Lead

Role Title: Technical Transfer Lead

Report to: Ilija Najdovski - Site PPM Lead

Location: Virginia, Brisbane

Working Pattern: 4 days office based/1 day remote

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. 

Role Summary

We are seeking a Process (MST) Lead to drive the successful commercialisation and technology transfer of New Product Developments (NPDs) from our Development Centre (DC) to our Manufacturing Site (MS).

This role is critical in ensuring that new products are transferred into manufacturing as robust, scalable, and compliant processes, supported by strong scientific understanding and clear manufacturing documentation. You will act as the key technical link between development and operations, with a strong appreciation of both formulation science and manufacturing realities.

Main Responsibilities

• Lead end-to-end technology transfer of NPDs, including scale-up, trials, validation, and manufacturing readiness.
• Translate formulation and development knowledge into efficient, site-ready manufacturing processes.
• Develop and maintain Manufacturing Instructions (MIs) and technical documentation.
• Act as the process Subject Matter Expert (SME), supporting troubleshooting across trials, validation, and routine production.
• Drive process robustness, continuous improvement, and innovation.
• Support process validation and ensure readiness for routine manufacturing.
• Collaborate with cross-functional teams including R&D (DC), Operations, Quality, Engineering, and Supply Chain.
• Ensure compliance with GMP and non-GMP requirements, with awareness of relevant regulatory expectations.
• Provide input into packaging and process integration, ensuring smooth downstream operations.

 Health, Safety and Environment: Cooperate with Management to:

• Provide and maintain systems of work, and working environments that are safe and without risks to health.

• Provide the information, instruction, training and supervision necessary to ensure the health and safety of employees.

• Consult with employees about OHS matters so that they can contribute to decisions affecting their health, safety and welfare.

• Ensure the health and safety of people visiting or working who are not employees by not exposing them to risk.

• Comply with corporate and legal health and safety requirements.

• Identify and correct unsafe conditions or behaviours and immediately notify the Manager of any serious incidents; complete and Incident / Injury Report and forward to People & Culture within 48 hours where necessary.

• Undertake duties in accordance with the current Opella Policies and Procedures.

• Report non-conformance in accordance with the requirements of the Opella quality system

About You

We believe that professionals with the following experience and skillsets are well-suited for this position:

• You are a technically strong and practically minded process professional with a solid grounding in both formulation science and manufacturing processes. You understand how formulation design influences process performance and are confident translating this knowledge into robust, scalable manufacturing solutions.
• You thrive at the interface between Development and Operations, acting as a bridge between theory and practice. You are comfortable challenging assumptions, asking the right scientific questions, and ensuring processes are not only compliant, but efficient and reliable at scale.
• You bring a structured, data-driven approach to problem solving and are highly effective at troubleshooting across formulation, process, and equipment interactions. You work collaboratively across functions, influencing stakeholders and aligning teams toward successful technology transfer outcomes.
• With strong ownership and adaptability, you manage competing priorities with focus and clarity, and are motivated by delivering high-quality, right-first-time product launches into routine manufacturing.

Essential Skills & Experience

• Degree in Chemistry, Formulation Science, Chemical Engineering, Pharmaceutical Sciences, or a related discipline (or equivalent experience).

• Minimum 5 years’ experience in MS&T/MST, process engineering, or technology transfer within a regulated manufacturing environment.

• Strong ability to translate scientific knowledge into practical manufacturing solutions.

• Proven problem-solving and troubleshooting capability.

• Confident working cross-functionally and managing multiple priorities in a fast-paced environment.

• Working knowledge of GMP/non-GMP environments and regulatory requirements.

Desirable Skills & Experience

• Experience working with or alongside formulation development, with understanding of how formulation attributes impact scale-up and manufacturability.

• Experience in scale-up and commercialisation of pharmaceutical, OTC, or FMCG products.

• Knowledge of process validation (PPQ) and lifecycle approaches (e.g. CPV).

• Familiarity with QbD and risk-based tools (e.g. FMEA).

• Experience with technical documentation (MIs, protocols, reports).

• Understanding of manufacturing equipment and key unit operations.

• Experience in deviation investigation, root cause analysis, and change control.

• Strong data analysis and problem-solving capability in a manufacturing environment.

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.