21 Sep
|
Probiotec
|
Victoria
21 Sep
Probiotec
Victoria
Job Description
Probiotec is a leading provider of contract manufacturing and packing services in the pharmaceutical and associated sectors, providing best-in-class solutions to a diverse range of clients. Since beginning operations in 1997, Probiotec has quickly emerged as a leading manufacturer and packer of a diverse, high-quality range of prescription ('Rx') and over-the-counter ('OTC') pharmaceuticals, complementary medicines and consumer health products.
n
The business is also one of Australia's largest packing companies, offering a multitude of packing services – including primary, secondary & co-packing capabilities as an end-to-end manufacturing and packing partner. With multiple sites across Australia including Probiotec Multipack, Probiotec LJM and Probiotec Pharma, the group is responsible for employing over 1000 employees nationwide. As a leader in Australian manufacturing and packing services, Probiotec provides innovative healthcare products that improve the lives and well-being of our customers.
n
NPD & Technical Transfer Scientist
n
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.
n
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.
n
Key Responsibilities and Accountabilities
n
n
- NPD Execution: Support the development of new products, including formulation trials, process development, and laboratory testing in line with technical specifications and client requirements.
n
- 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.
n
- Process Development & Scale-Up: Contribute to the optimisation and scale-up of manufacturing processes, ensuring consistency, reproducibility, and product quality during commercialisation.
n
- Troubleshooting and Investigation: Support investigations into technical issues during development and manufacturing, including deviations, process inefficiencies, and equipment-related challenges.
n
- Regulatory and GMP Compliance: Ensure all development and technical transfer activities are conducted in accordance with cGMP requirements and relevant regulatory standards.
n
- Cross-Functional Collaboration: Work closely with internal stakeholders, including Quality, Manufacturing, and Regulatory Affairs, to ensure alignment on product specifications, timelines, and compliance requirements.
n
- Documentation:
Prepare and maintain accurate technical documentation, including development reports, batch records, validation protocols, and technical transfer documentation, in a timely manner.
n
- Continuous Improvement: Identify opportunities to improve development and transfer processes to enhance efficiency, reduce costs, and improve product robustness.
n
n
Essential Qualifications
n
Required Educational Credentials
n
n
- Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology, or a related discipline.
n
n
Required Experience and Skills
n
n
- Experience in pharmaceutical manufacturing, product development, or technical transfer environments.
n
- Working knowledge of cGMP requirements.
n
- Solid analytical and problem-solving skills.
n
- Ability to interpret technical data and contribute to investigations.
n
- Effective communication skills and the ability to work within cross-functional teams.
n
- High level of attention to detail and documentation accuracy.
n
n
Preferred Qualifications
n
n
- Experience in formulation development and/or process scale-up within a pharmaceutical.
n
- Experience in solid dose formulations would be an advantage.
n
- Understanding of technical transfer processes from development to commercial manufacturing.
n
- Familiarity with validation activities (e.g. process validation, cleaning validation).
n
- Exposure to regulatory requirements and documentation standards.
n
- Ability to manage multiple tasks and meet project timelines in a fast-paced environment.
n
📌 NPD & Technical Transfer Scientist (Victoria)
🏢 Probiotec
📍 Victoria