What are the responsibilities and job description for the Ligand Binding Analytical Scientist I position at AMS?
The Analytical Chemist II is responsible for the development, optimization, and validation of analytical methods to support research, study development. This role requires hands-on experience with analytical techniques, strong problem-solving skills, and the ability to work independently while contributing to cross-functional teams in a regulated environment.
Key Responsibilities
Method Development & Validation
- Develop, optimize, and validate analytical methods in accordance with ICH, USP, EP, and company SOPs.
Analytical Testing & Data Integrity
- Conduct routine and non-routine analysis of raw materials, in-process samples, finished products, and stability samples.
- Generate, analyze, and interpret analytical data using appropriate tools.
- Ensure data integrity and compliance with ALCOA principles, GCP, and regulatory requirements.
Instrumentation & Technical Knowledge
- HPLC / UPLC
- GC
- UV-Vis
- Dissolution systems
- Support qualification, calibration, and preventive maintenance of laboratory equipment.
Documentation & Compliance
- Prepare and review validation protocols, analytical reports, SOPs, and method transfer documentation.
- Support regulatory submissions, audits, and inspections by providing technical documentation and responses.
- Participate in investigations, deviations, CAPAs, and change controls related to analytical methods.
Required Qualifications
Education
- Bachelor’s degree in Chemistry, Analytical Chemistry, or a related scientific discipline (required)
Experience
- 1- 2 years of experience in an analytical laboratory environment
- Demonstrated experience in analytical method development and validation
- Experience working in CRO-regulated industries (pharmaceutical, biotech, chemical, or medical devices)
Technical Skills
- Expertise with chromatographic techniques (HPLC/UPLC, GC)
- Solid understanding of analytical develop, validation principles and regulatory guidelines
- Proficiency in laboratory software and data systems
Soft Skills
- Strong analytical and problem-solving abilities
- Attention to detail and commitment to data accuracy
- Effective written and verbal communication skills
- Ability to manage multiple priorities and meet deadlines
- Team-oriented mindset with the ability to work independently