Project Chemist (Analytical Method & Research Development)

Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results. Learn more at About the Role The Project Chemist is a key contributor to analytical development, routine and non-routine testing, and project coordination activities supporting lot release, stability studies, and client deliverables. This role requires strong technical expertise in analytical chemistry particularly HPLC along with the ability to manage testing timelines, maintain regulatory compliance, and coordinate project-related activities across teams. Responsibilities Perform development, optimization, validation, and transfer of analytical methods to support assay quantitation, lot release, and stability studies. Conduct qualitative and quantitative testing of routine and non-routine client samples in a timely manner. Track and meet assigned testing deadlines; proactively communicate risks or delays to the Supervisor or Manager. Review, interpret, and document test results accurately in computerized data systems. Promptly escalate unexpected or out-of-specification results and participate in root cause analysis with minimal supervision. Perform maintenance, calibration, and troubleshooting of assigned laboratory equipment and systems. Ensure all instruments operate within established calibration and performance guidelines. Maintain proficiency with all applicable laboratory equipment, systems, and standard operating procedures (SOPs). Stay current with emerging analytical technologies and instrumentation, with a strong emphasis on HPLC applications in the pharmaceutical industry. Provide cross-functional laboratory support and backup coverage across workstations as needed. Maintain complete, accurate, and current documentation in compliance with company policies and regulatory standards. Write, revise, and review SOPs and technical documentation as required. Comply with ISO 17025, cGMP, cGLP, and Quality Control guidelines. Support laboratory compliance, quality, and safety audits as required. Maintain a clean, organized, and safe laboratory work environment while adhering to all safety requirements. Meet with Supervisors or Managers to understand project scope, objectives, and deliverables. Coordinate project activities, schedules, and timelines across involved team members. Ensure project scope, expectations, and changes are clearly communicated to all stakeholders. Compile and maintain interim project reports and documentation. Communicate schedule changes, evolving requirements, and unexpected events promptly and effectively. Participate in team discussions and contribute to achieving departmental and organizational goals. Work independently while collaborating effectively within cross-functional teams. Perform additional duties as assigned to support laboratory and business needs. Qualifications Ph.D., Master’s, or Bachelor’s degree in Analytical Chemistry or a related scientific field, including a minimum of twelve (12) semester hours in chemistry. Minimum of three (3) years of experience in an analytical laboratory, or an equivalent combination of education and experience. Certified Pharmacy Technician credentials are a plus. Required Skills Hands-on experience with sample preparative chemistry, wet chemistry analysis, and modern instrumental analysis techniques. Strong competence with laboratory-related computer applications and data management systems. Knowledge of project coordination, sampling methods, and quality control systems. Familiarity with laboratory practices in compliance with regulatory and quality standards. #J-18808-Ljbffr