American Injectables is a fast-growing pharmaceutical CDMO, dedicated to developing and manufacturing high-quality drug products. Our R&D Laboratory is seeking a detail-oriented and experienced Analytical Development Scientist to support analytical method development, validation, and transfer for multiple projects.
Job Summary
The Analytical Development Scientist will play a key role in developing, validating, and transferring analytical methods to support drug product development, manufacturing, and regulatory submissions. This role requires hands-on expertise with HPLC/UPLC, mass spectrometry (MS), and dissolution testing, along with experience in GMP compliance and regulatory guidelines. The ideal candidate will be comfortable working in cross-functional teams and with external CROs/CMOs to ensure successful execution of analytical activities.
Key Responsibilities
Analytical Method Development & Validation
Develop, validate, and transfer analytical methods for raw materials, in-process materials, finished products, and stability studies.
Perform hands-on bench work, including HPLC/UPLC method development, impurity identification with mass spectrometry (MS), and method transfer/validation.
Troubleshoot and optimize analytical methods, applying strong problem-solving skills.
Design and execute analytical studies, analyze data, interpret results, and prepare study protocols and reports.
Regulatory & Compliance Support
Prepare and review regulatory submission documents, including responses to regulatory deficiencies.
Ensure compliance with cGMP, FDA, ICH guidelines, and compendial requirements (USP/NF, EP).
Maintain accurate laboratory records in accordance with Good Documentation Practices (GDP).
Cross-Functional Collaboration & Project Support
Represent analytical development in cross-functional teams, ensuring alignment with project objectives.
Collaborate with manufacturing, quality, and automation teams to support method development and transfer.
Work with CROs/CMOs to coordinate external analytical testing as needed.
Laboratory Operations & Safety
Assist in laboratory instrument maintenance and troubleshooting.
Adhere to health, safety, and environmental requirements.
Occasionally work extended hours based on project needs.
Qualifications & Skills
Required Skills & Abilities
Strong experience with HPLC/UPLC, GC, mass spectrometry (MS), and dissolution testing.
Familiarity with physicochemical characterization techniques such as particle size analysis, TGA, and DSC.
Knowledge of FDA, ICH guidelines, and compendial methods (USP/NF, EP).
Ability to work independently and collaboratively in cross-functional teams.
Strong problem-solving, data analysis, and organizational skills.
Proficiency in Microsoft Office (Word, Excel, PowerPoint) for documentation and reporting.
Excellent written and verbal communication skills for report writing and presentations.
Education & Experience
M.S. in Chemistry, Analytical Chemistry, or a related field with at least 2 years of relevant pharmaceutical R&D experience.
B.S. in Chemistry or a related field with at least 5 years of relevant experience.
Strong candidates with equivalent education and experience combinations will be considered.
Other Requirements
Must be eligible to work in the USA.
Why Join Us?
Be part of an innovative pharmaceutical CDMO with cutting-edge R&D projects.
Work in a collaborative and dynamic environment, supporting high-impact drug development.
Competitive salary, benefits, and opportunities for career growth.