Analytical Development Specialist
hace 4 semanas
We are excited to be recruiting on behalf of a leading global CDMO for the position of Analytical Development Chemist. This organization is renowned for its innovative approach to pharmaceutical development, providing a comprehensive range of analytical services to support the entire drug development process.
Key Responsibilities:- Develop, qualify, and validate new analytical methods to support process development and other stages of drug development.
- Coordinate sample testing and analytical activities, applying techniques such as reverse and normal phase (U)HPLC-UV, GC-FID, LC-MS, GC-MS, and more for drug substance analysis and control.
- Review and interpret external analytical data packages provided by customers.
- Present scientific data and participate in RD group meetings, representing the Analytical Development team when necessary.
- Perform analytical tasks individually to support process development, regulatory submissions, and lot release.
- Troubleshoot analytical methods and resolve technical challenges during method development.
- Ensure compliance with cGXP standards, regulatory requirements, and company procedures.
- Write and review technical reports, SOPs, and Tech Transfer documents, maintaining precise and accurate documentation.
- Degree in Chemistry, Analytical Chemistry, or a related discipline.
- Strong communication skills in English, both written and verbal (Spanish is a plus but not mandatory).
- Minimum of 2-3 years of experience in an Analytical Development laboratory; experience in QC laboratories is also valuable.
- Hands-on expertise in analytical techniques such as (U)HPLC-UV, GC-FID, LC-MS, GC-MS, and other drug substance characterization methods.
- Ability to work methodically and collaboratively within a team-oriented environment.
This Analytical Development Chemist position offers an exciting opportunity to work with a global leader in the CDMO industry, playing a pivotal role in the development of new analytical methods and supporting innovative pharmaceutical processes.
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