Company

We are a Global Business leading the market with Australian made and owned dental restorative products, teeth whitening and small equipment. Founded in 1972, SDI products are now distributed in over 100 countries throughout the world. Our global head office and manufacturing plant is located in Melbourne with overseas branch offices and warehousing in the USA, Brazil and Germany.

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Summary of Role

The Manufacturing Process Chemist provides technical support to SDI manufacturing operations, with a focus on chemical formulations, raw materials, process parameters and product performance. The role troubleshoots production issues, supports investigations and quality-system activities, and contributes to validation, manufacturing trials and process improvement in accordance with approved procedures, GMP and applicable quality and regulatory requirements.

Key Responsibilities
1. Manufacturing Support and Process Improvement

- Provide day-to-day technical support to Production for formulation, raw-material, equipment-interaction and process issues.
- Troubleshoot batch and process problems and recommend practical, risk-based solutions that support product quality, consistency, yield and efficiency.
- Review batch records, manufacturing data and test results to identify variation, trends and improvement opportunities.
- Implement approved process improvements and assess their effectiveness using manufacturing and quality data.

2. Investigations, CAPA and Change Control

- Lead or support investigations into nonconforming product, raw materials, formulations, equipment and manufacturing processes.
- Apply structured root cause analysis and risk assessment using manufacturing history, testing and technical evidence.
- Develop corrective and preventive actions, including suitable effectiveness checks where required.
- Prepare and progress change controls for raw materials, suppliers, formulations, equipment, processes, specifications and manufacturing documents within agreed timelines.

3.



Validation and Manufacturing Trials

- Plan and execute assigned manufacturing trials, process validations and equipment qualification activities with Production and Quality.
- Prepare fit-for-purpose protocols, trial plans, risk assessments, data evaluations and reports.
- Support formulation scale-up, process transfer and introduction of new or modified products, materials and processes into manufacturing.
- Review trial and validation outcomes, identify risks and recommend follow-up actions or improvements.

4. Documentation, Compliance and Training

- Prepare and maintain manufacturing procedures, work instructions, master manufacturing documents, troubleshooting guides and technical reports.
- Maintain accurate and traceable records for investigations, CAPAs, change controls, validations and trials.
- Work in accordance with GMP, valuable documentation practices, workplace safety requirements and the SDI Quality Management System.
- Provide technical input to audits and inspections, and deliver knowledge transfer for new or revised materials, formulations, equipment and processes.

Key Relationships

Internal

Production; Quality Assurance; Quality Control; Research & Development; Supply Chain and Planning; Engineering; Regulatory Affairs

External

Raw-material and equipment suppliers; contractors; laboratories; technical service providers

Qualifications, Experience and Skills

- Bachelor's degree in Chemistry, Applied Chemistry, Chemical Engineering, Pharmaceutical Science or a related scientific discipline.
- Minimum two years of relevant experience in manufacturing,



process chemistry, pharmaceuticals, medical devices or another regulated industry.
- Hands-on experience supporting chemical or formulation-based manufacturing and troubleshooting process issues.
- Experience with investigations, root cause analysis, risk assessment, CAPA, change control and controlled technical documentation.
- Sound applied chemistry knowledge relating to formulations, raw materials, mixing, processing behaviour and finished-product performance.
- Working knowledge of GMP, good documentation practices and quality management systems.
- Strong analytical, problem-solving, data-interpretation and written communication skills.
- Ability to manage competing priorities, work independently with appropriate guidance and collaborate across functions.
- Competence in Microsoft Excel and Word.

Personal Attributes

Practical and solutions focused; careful and accurate; accountable and reliable; collaborative; safety and quality conscious; willing to raise concerns where product quality, compliance or safety may be affected; demonstrates SDI values of passion, accountability, respect, teamwork and innovation.

Desirable Experience

- Medical device or pharmaceutical manufacturing; process validation, equipment qualification or manufacturing trials.
- Statistical analysis, process capability or data visualisation; SAP or a similar ERP system.
- Scale-up, technology transfer or introduction of new products and processes into manufacturing.

Job Environment

Office, laboratory and manufacturing-floor work involving production equipment, chemical raw materials and controlled documentation. Compliance with site safety requirements, risk controls and personal protective equipment is mandatory. Occasional flexibility may be required to support urgent manufacturing issues or trials.

If you are tertiary qualified and are looking for a great career in manufacturing, please apply, now!

📌 Manufacturing Process Chemist (Bayswater)
🏢 SDI
📍 Bayswater