Analytical Development Scientist Position Available In Hernando, Florida

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 c

GMP, 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 .