Job Reference: J5634538
Updated On: 03/03/2021
Status: Open to Applications
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Role OverviewWe are currently looking for a Principal Scientist - Drug Product Development to join a leading Biopharmaceutical company based in the North West of the UK. As the Principal Scientist - Drug Product Development you will be responsible for leading a range of Process Development projects to deliver robust Drug Product and Fill Finish Manufacturing processes for both Clinical and Commercial Biological Therapeutics.
This is an exciting opportunity to join a Leading Biologics Manufacturing business who have recently built a brand new facility within commutable distance from Liverpool. This is a rare opportunity to be a Subject Matter Expert and act as Project Lead for late-stage clinical programmes.
Key Duties and ResponsibilitiesYour duties as the Principal Scientist - Drug Product Development will be varied however the key duties and responsibilities are as follows:
1. Provide technical leadership for the design, development, technology transfer and validation of fit-for-purpose, robust drug product manufacturing processes to effectively support biologic products developed. As well as drive the implementation of effective Drug Product fill-finish processes and technologies.
2. Lead effective Design of Experiments (DoE) for process development and optimisation including implementation of appropriate Quality by Design (QbD) control strategies in co-ordination with analytical and process development requirements.
3. Proactively Support CMC Project Management (Technical Leaders and Project Managers), incorporating Drug Product expertise and requirements across assigned CMC programs, and more broadly as a subject matter expect (SME). You will also liaise directly with key stakeholders in the business to drive Biologic strategy.
4. Drive and monitor compliance with relevant regulations including GMP and GLP as well as EHS and Quality guidelines.
Role RequirementsTo be successful in your application to this exciting opportunity as the Principal Scientist - Drug Product Development we are looking to identify the following on your profile and past history:
1. Relevant degree in a a Biological of Chemical field in addition to extensive industry experience working with Drug Products.
2. Proven industry experience in the process development of Drug Product Manufacturing where you have used statistical analytical tools such as Quality by Design and Design of Experiment.
3. A working knowledge and practical experience with Biological products is beneficial for this position but small molecule and NCE experience will be considered. Experience with Lyophilisation is highly beneficial.
Key Words: Biologics | Biopharmaceutical | Drug Product | Process Development | Design of Experiment | DoE | Quality by Design | QbD | Project Management | Lyophilaisation | Freeze Dry | Technical Transfer | Manufacturing | Fill-Finish
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