Analytical Development Chemist
hace 3 días
**General responsabilities**:
This individual will be responsible for the development, qualification and eventual validation of new analytical methods, co-ordination of sample testing to support process development and other developments activities at all stages of development.
Review and familiarization of external analytical data packages provided by customers.
The analytical techniques include, but are not limited to: reverse and normal phase (U)HPLC-UV, GC-FID, LC-MS, GC-MS etc. that may be applied for comprehensive understanding of drug substance development, análisis and control.
This individual will be required to present and interpret scientific data, write technical reports and represent the Analytical Development team in matrix team or R&D group meetings when needed.
**Specific Responsibility**:
Laboratory work as Analyst within the Analytical development department.
Performs the assigned analytical tasks individually in support of process development, registration, lot release, pre and post regulatory submission activities.
Performs activities within the assigned timelines and in compliance with cGXP’s, regulatory requirements and company practices and procedures.
Development, qualification and validation of new analytical methods. Identifies technical challenges during analytical method development and perform method trouble shooting.
Proactively participates in activities in support of process development
Communicates effectively with peers, supervisor and management about the status of the assigned activities.
Write and review technical and data analysis reports, SOPs, Tech Transfer documents and maintain accurate, precise, legible documentations when required.
**Experience and personal skills**:
Education: Preferably holds a degree in chemistry, analytical chemistry or other related disciplines preferred.
Languages: Excellent communication and interpersonal skills in English and Spanish, both written and verbal are required. (Spanish is not a must).
Experience: Minimum of 2-3 years within Analytical Development laboratory, experience in QC laboratories will also be valuable
Hands-on experience and expertise in analytical methods such as (U)HPLC-UV, GC-FID, LC-MS, GC-MS and other related drug substance characterization techniques.
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