Analytical Development Scientist at ESTEVE Analytical Development Scientist at ESTEVE in Winnetka, Illinois Posted in 2 days ago.

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full-time The Analytical Development Scientist is responsible for developing, optimizing, validating, and transferring analytical methods that support the development and manufacturing of pharmaceutical products. This role partners closely with Quality Control, Manufacturing, Regulatory Affairs, Validation, and Technical Services to ensure analytical methods are scientifically sound, compliant with regulatory requirements, and aligned with business objectives. The successful candidate demonstrates strong technical expertise, a commitment to continuous improvement, and the ability to collaborate effectively across functions while supporting ESTEVE's culture of quality, safety, integrity, and operational excellence. Job Responsibilities Develop, optimize, validate, and transfer analytical methods for raw materials, intermediates, APIs, and finished products Perform analytical testing using techniques including HPLC, GC, dissolution, UV-Vis, FTIR, KF, and other applicable laboratory instrumentation Interpret, analyze, and document experimental data in accordance with GMP requirements and data integrity principles Author and review analytical methods, protocols, reports, specifications, and standard operating procedures (SOPs) Investigate laboratory deviations, out-of-specification (OOS), out-of-trend (OOT), and atypical results and implement effective corrective and preventive actions Support process development, process validation, cleaning validation, and manufacturing investigations as needed Collaborate with internal and external stakeholders to support technology transfer activities and new product introductions Ensure laboratory activities comply with cGMP, FDA, ICH, and other applicable regulatory requirements Participate in continuous improvement initiatives focused on quality, productivity, efficiency, and compliance Maintain laboratory equipment and support qualification, calibration, and maintenance activities Contribute to regulatory submissions, audits, and inspections by providing technical documentation and subject matter expertise Promote and adhere to all Environmental, Health, and Safety (EHS) requirements and company policies Job Requirements Required Bachelor's degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or related scientific discipline Minimum of 3-5 years of pharmaceutical analytical development, quality control, or related laboratory experience Strong knowledge of chromatographic and analytical techniques, including HPLC and GC Experience working in cGMP-regulated environments Strong problem-solving, technical writing, and data analysis skills Proficiency with laboratory software and Microsoft Office applications Excellent verbal and written communication skills Preferred Advanced degree (M.S. or Ph.D.) in Chemistry or related scientific discipline Experience with method validation, method transfer, and regulatory submissions Knowledge of ICH, USP, EP, and FDA guidance documents Experience supporting commercial pharmaceutical manufacturing operations