Senior Chemist

New York Technology Partners; City of Rochester (NY); Presencial; USD 90.000 - 140.000; Jornada completa

Descripción de la vacante

New York Technology Partners in Rochester seeks an experienced scientist to lead Analytical Method Development & Validation for regulated pharmaceutical projects. You will design, develop, validate, and transfer methods with limited supervision, acting as SME on product transfers.

You will write protocols, reports, and data packages, review peer data for accuracy and compliance, and mentor lab staff in best practices.

Formación

• Bachelor's, Master's, or Ph.D. in Chemistry or related field.
• Strong experience in analytical method development and validation in regulated environments.
• Experience supporting GMP laboratory operations and quality systems.
• Ability to lead complex technical projects independently.
• Strong technical writing for protocols, investigations, and reports.
• Experience interacting with regulatory agencies and audits is desirable.
• Excellent communication, collaboration, and leadership skills.

Responsabilidades

• Design, develop, validate, and transfer analytical methods with minimal supervision.
• Serve as SME on new product development and product transfer projects.
• Write and execute protocols, reports, and analytical data packages.
• Review analytical data for accuracy, compliance, and data integrity.
• Lead investigations related to laboratory incidents and CAPAs.
• Provide analytical expertise to support manufacturing and quality initiatives.
• Mentor and train laboratory personnel on methods and best practices.
• Evaluate regulatory updates and support audits/inspections.

Conocimientos

Analytical Method Development

Validation

Troubleshooting

Regulatory Compliance

Technical Writing

Leadership

Quality Systems

GMP

Audits

Educación

Bachelor's degree in Chemistry

Master's or PhD in related field

Descripción del empleo

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.
• 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.
• 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.