Senior Scientist, Analytical Methods & Lab Leadership

Actalent; New York (NY); On-site; USD 120,000 - 160,000; Full time

Job summary

Actalent is seeking a Senior Scientist in New York to independently develop, validate, and author analytical methods for new and existing products, ensuring that all activities comply with SOPs and regulations. The role emphasizes testing development materials and stability samples while maintaining laboratory instrumentation.

The candidate will train staff, transfer validated procedures, review data and notebooks, and support root cause analysis to uphold quality and regulatory standards across

Qualifications

• Bachelor’s degree in Chemistry with 8–10 years of experience (or Master’s with 6–8 years)
• Experience validating analytical test methods and instrument calibration.
• Proficiency with LabX, LIMS, Empower, and data processing tools.

Responsibilities

• Independently develop, validate, and write analytical methods for new development and existing products in accordance with standard operating procedures.
• Test new development raw materials and pilot lot stability samples using appropriate analytical techniques.
• Develop, write, and implement instrument calibration and qualification methods for laboratory equipment.
• Calibrate, qualify, and maintain laboratory instruments to ensure accurate and reliable performance.
• Advise laboratory personnel on new analytical methods, instrument operation, and computer-based data analysis.
• Assist in troubleshooting analytical methods, instrumentation issues, and data anomalies, and drive resolution of technical problems.
• Ensure research and development methods, techniques, and testing procedures comply with government regulations and internal policies and procedures.
• Transfer validated test procedures to appropriate laboratory groups, including preparing documentation and conducting training for technology transfer.
• Inspect and review the work of other scientists to ensure compliance with methods, procedures, and quality standards.
• Train personnel in new analytical methods, instrument operation, and computer analysis of data.
• Test finished products, raw materials, and drug product components using established methodologies.
• Review paperwork, software-generated results, and laboratory notebooks for accuracy, completeness, and compliance.
• Provide timely and appropriate feedback on test results and documentation based on established procedures.
• Perform investigational testing to support root cause analysis and resolution of product or process issues.
• Prepare clear and concise reports for management as required or requested, summarizing test results, investigations, and method validations.
• Maintain research and development functions related to new active ingredients, raw materials, and other components.
• Validate test methods for active ingredients, impurities and degradation products, raw materials, preservatives, and solvents using state-of-the-art analytical techniques.
• Assist in the creation and support of new product applications by providing analytical and technical input.
• Perform accelerated and nominal stability testing of new drug products and interpret results to support product development and shelf-life assessments.
• Support quality assurance, internal audits, compliance activities, inspections, and quality control initiatives as needed.

Skills

Analytical method development

Instrument calibration

Data analysis

Leadership

Team collaboration

Problem solving

Education

Bachelor’s degree in Chemistry

Master’s degree in Chemistry

Tools

LabX

LIMS

Empower

Excel

Word

Job description

Actalent is seeking a Senior Scientist in New York to independently develop, validate, and author analytical methods for new and existing products, ensuring that all activities comply with SOPs and regulations. The role emphasizes testing development materials and stability samples while maintaining laboratory instrumentation.

The candidate will train staff, transfer validated procedures, review data and notebooks, and support root cause analysis to uphold quality and regulatory standards across