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Probiotec is currently seeking an experienced and innovative NPD Lead to join our dynamic team - An exciting opportunity to drive new product development initiatives and contribute to our growth in the pharmaceutical industry.
Key Responsibilities:
* Lead end-to-end development of new pharmaceutical products across all dosage forms, from concept through scale-up and technology transfer.
* Develop, validate, and transfer analytical methods in accordance with ICH Q2(R1) guidelines.
* Conduct Cleaning Validation studies in line with ICH, FDA, EMA, and WHO requirements.
* Collaborate cross-functionally with QA, QC, Regulatory, and Manufacturing teams to ensure seamless project execution.
* Prepare and review technical documentation for regulatory submissions (Test method validation- protocols and reports).
Desirable Qualifications & Experience:
* Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field.
* 5 years of post-qualification experience in pharmaceutical R&D.
* Experience in a GMP-regulated environment.
* Proven senior-level expertise in Method Validation as per ICH Q2(R1) guidelines.
* Analytical Method Development and troubleshooting using HPLC including related substances.
* Experience in Cleaning Validation Analytical Method Development.
* Strong understanding of ICH, FDA, EMA, and WHO regulatory frameworks.
* Demonstrated ability to lead complex projects and manage timelines effectively.
* Excellent communication skills, both written and verbal.
About Probiotec:
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.
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, Southpack Laboratories, ABS, 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.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Science
* Industries
Pharmaceutical Manufacturing
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