Project Chemist (Analytical Method & Research Development)

Position Summary

What You Will Do

• 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.

Who You Are

•  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.
• 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.
• Certified pharmacy technician, a plus

Who We Are