Qualified Person
Recursion
πRemote - Worldwide
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Job highlights
Summary
Join our mission to decode biology and radically improve lives, while doing the most impactful work of your life. This role will be instrumental in ensuring that clinical trials associated with Recursion programs are able to expand into any region in the world!
Requirements
- Degree in a relevant field (e.g. pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology)
- 6+ years of pharmaceutical CMC/ QA experience
- Experience in building and implementing the infrastructure needed to support batch certifications for UK and EU use
- Must be certified as a Qualified Person in the EU and UK
- Hands on experience with small molecule API manufacturing processes, solid oral drug product manufacturing and finished goods packaging
- Strong understanding of (early phase) clinical trials, a broad understanding of drug development and therapeutic area knowledge relevant to Recursionβs pipeline, and internal strategies/tactics and external trends
- Solid understanding of ICH, FDA, and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of pharmaceutical development
- Demonstrated ability, ideally in a smaller company, to flex between setting strategic direction and jumping in to get the work done
- Ability to work 35-40 hours per week across multiple time zones
Responsibilities
- Create world-class internal infrastructure to enable certification of materials for use in EU and UK clinical trials
- Lead the implementation of fit-for-purpose quality systems and processes enabling the expansion of clinical trials beyond the United States into the EU and UK
- Partner across Recursion to drive a quality-minded, innovative culture and identify next-generation, industry-leading technologies to support our development programs through the delivery of investigational medicines
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Please let Recursion know you found this job on JobsCollider. Thanks! π