Analytical Scientist I: Method Development & Validation

Meet Life Sciences

Morrisville (NC)

On-site

USD 65,000 - 90,000

Full time

12 hours ago

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Job summary

Meet Life Sciences in Morrisville, NC seeks an Analytical Scientist I to support API development programs through analytical method development, optimization, qualification, and validation. This role will perform laboratory experiments, analyze data, troubleshoot analytical equipment, and prepare technical documentation in compliance with cGMP, SOPs, and regulatory requirements.

The position emphasizes hands-on work with HPLC, GC, FTIR, KF, XRPD and related techniques, with collaboration across

Qualifications

Bachelor's degree in Analytical Chemistry or related field with 4+ years of experience.
Master's degree with 2+ years of industrial experience.
Ph.D. with 0-1+ years of industrial experience.
Hands-on experience with analytical method development, qualification, or validation.
Strong knowledge of analytical techniques, particularly HPLC and GC.
Understanding of cGMP requirements and analytical laboratory practices.
Strong data analysis, technical writing, and problem-solving skills.
Ability to work independently and collaboratively in a fast-paced environment.

Responsibilities

Develop, optimize, qualify, and validate analytical methods for drug substances.
Execute experiments using HPLC, GC, GC-HS, FTIR, KF, XRPD, particle size analysis, and HPLC-MS.
Analyze and interpret data and recommend follow-up activities.
Prepare analytical methods, development reports, protocols, and validation documentation.
Perform routine equipment maintenance and troubleshooting.
Coordinate activities with contract analytical and testing laboratories as needed.
Maintain compliance with cGMP, SOPs, training, and applicable regulatory requirements.