Analytical Development Chemist

General Responsibilities: This individual will be responsible for the development, qualification, and eventual validation of new analytical methods, coordination of sample testing to support process development, and other development activities at all stages of development.
Review and familiarization with 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, analysis, 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 RD group meetings when needed.
Specific Responsibilities: Laboratory work as an 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, regulatory requirements, and company practices and procedures.
Development, qualification, and validation of new analytical methods.
Identifies technical challenges during analytical method development and performs method troubleshooting.
Proactively participates in activities in support of process development.
Communicates effectively with peers, supervisors, and management about the status of the assigned activities.
Writes and reviews technical and data analysis reports, SOPs, Tech Transfer documents, and maintains accurate, precise, legible documentation when required.
Experience and Personal Skills: Education: Preferably holds a degree in chemistry, analytical chemistry, or other related disciplines.
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 an 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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