Analytical Development Scientist

Job Description

About Us

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.