The NPD & Technical Transfer Scientist supports the development and transfer of new products from concept through to commercial manufacturing. This role works closely with cross‐functional teams, including Manufacturing, Quality, and Regulatory Affairs, to ensure products are developed, scaled, and transferred in a compliant and efficient manner.
The primary responsibility of this role is to execute formulation, development, and technical transfer activities, ensuring all work meets internal quality standards and regulatory requirements.
Key Responsibilities and Accountabilities
* NPD Execution: Support the development of new products, including formulation trials, process development, and laboratory testing in line with technical specifications and client requirements.
* Technical Transfer Support: Assist in transferring products and processes from development into manufacturing, including preparation of technical transfer documentation and support during scale‐up activities.
* Process Development & Scale‐Up: Contribute to the optimisation and scale‐up of manufacturing processes, ensuring consistency, reproducibility, and product quality during commercialisation.
* Troubleshooting and Investigation: Support investigations into technical issues during development and manufacturing, including deviations, process inefficiencies, and equipment‐related challenges.
* Regulatory and GMP Compliance: Ensure all development and technical transfer activities are conducted in accordance with cGMP requirements and relevant regulatory standards.
* Cross‐Functional Collaboration: Work closely with internal stakeholders, including Quality, Manufacturing, and Regulatory Affairs, to ensure alignment on product specifications, timelines, and compliance requirements.
* Documentation: Prepare and maintain accurate technical documentation, including development reports, batch records, validation protocols, and technical transfer documentation, in a timely manner.
* Continuous Improvement: Identify opportunities to improve development and transfer processes to enhance efficiency, reduce costs, and improve product robustness.
Essential Qualifications
Required Educational Credentials
* Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology, or a related discipline.
Required Experience and Skills
* Experience in pharmaceutical manufacturing, product development, or technical transfer environments.
* Working knowledge of cGMP requirements.
* Strong analytical and problem‐solving skills.
* Ability to interpret technical data and contribute to investigations.
* Effective communication skills and the ability to work within cross‐functional teams.
* High level of attention to detail and documentation accuracy.
Preferred Qualifications
* Experience in formulation development and/or process scale‐up within a pharmaceutical.
* Experience in solid dose formulations would be an advantage.
* Understanding of technical transfer processes from development to commercial manufacturing.
* Familiarity with validation activities (process validation, cleaning validation).
* Exposure to regulatory requirements and documentation standards.
* Ability to manage multiple tasks and meet project timelines in a fast‐paced environment.
Work Location
Your primary work location will be Probiotec Pty Ltd, 83 Cherry Lane, Laverton North, VIC 3026.
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