Senior Chemist

Key Responsibilities

Analytical Method Development & Validation

• Design, 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 & Troubleshooting

• Lead 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 Support

• Provide 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 & Innovation

• Evaluate 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 & Leadership

• Develop 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.

Qualifications

• Bachelor'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.