Senior Chemist

Key ResponsibilitiesAnalytical Method Development & ValidationDesign, develop, validate, and transfer analytical methods with minimal supervision.Serve as the analytical subject matter expert (SME) on new product development and product transfer projects.Write and execute protocols, reports, and analytical data packages.Review analytical data generated by peers to ensure accuracy, compliance, and data integrity.Provide technical guidance on analytical approaches and test methods.Laboratory Investigations & TroubleshootingLead investigations related to laboratory incidents, deviations, and analytical issues.Perform root cause analysis and assess potential product impact.Develop and implement corrective and preventive actions (CAPAs).Collaborate with Quality, Manufacturing, and Technical Operations teams to reduce recurring deviations and improve process reliability.Serve as an analytical lead during customer and regulatory inspections.Manufacturing & Quality SupportProvide analytical expertise to support commercial manufacturing, process development, and troubleshooting activities.Develop solutions that minimize laboratory and manufacturing downtime.Support quality system improvements and laboratory compliance initiatives.Act as a technical resource for Quality Assurance laboratories.Continuous Improvement & InnovationEvaluate regulatory and compendial updates, including USP and Ph. Eur. changes.Investigate new analytical technologies and methodologies to improve testing efficiency and effectiveness.Recommend instrumentation upgrades and laboratory investments that drive operational efficiencies.Lead process improvement initiatives that enhance laboratory performance and compliance.Training & LeadershipDevelop and deliver laboratory training programs and technical instruction.Mentor and train laboratory personnel on analytical methods, procedures, and best practices.Evaluate training effectiveness and recommend continuous learning strategies.Support employee development through both individual and group training initiatives.QualificationsBachelor's, Master's, or Ph.D. in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or a related scientific discipline.Strong experience in analytical method development, validation, and troubleshooting within a regulated pharmaceutical, biotechnology, or life sciences environment.Experience supporting GMP laboratory operations and quality systems.Demonstrated ability to lead complex technical projects independently.Strong technical writing skills, including protocols, investigations, and technical reports.Experience interacting with regulatory agencies and supporting audits/inspections is highly desirable.Excellent communication, collaboration, and leadership skills.