Job Opportunity
The CMC Manager will lead drug product validation and commercialisation activities for new pharmaceutical development projects. This includes the management of continuous improvement projects for commercial products, supporting the development and manufacture of pharmaceutical dosage forms and devices, and ensuring process validation in accordance with FDA standards.
Key Responsibilities:
* Lead drug product validation and commercialisation activities for new pharmaceutical development projects
* Manage continuous improvement projects for commercial products
* Support the development and manufacture of pharmaceutical dosage forms and devices
* Ensure process validation in accordance with FDA standards
Requirements:
To be successful in this role, you will need a degree in Chemistry, Analytical Chemistry, Pharmacy or related field at 2.1 or higher. You must also have at least 5 years of practical experience working in pharmaceutical development or manufacturing, including 2 years of experience in drug product Process Performance Qualifications and associated activities.
Skill Set:
A strong knowledge of ICH, FDA and EMA Process Performance Qualification and Process Validation guidelines is essential. Additionally, you should have hands-on experience in the manufacture of drug products and execution of PPQ/Validation batch manufacture. Proficiency in statistical software applications such as MiniTab and good communication skills are also required.
About the Role:
This is an exciting opportunity to join a young and ambitious pharmaceutical company as a CMC Manager. As a key member of the team, you will play a vital role in managing pharmaceutical development and technology projects to deliver the development pipeline and support existing commercial products.