Senior Analytical Method Validation Scientist

Katalyst CRO; Thousand Oaks (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Katalyst CRO in Thousand Oaks, CA invites a senior analytical development professional to drive method validation and transfer across laboratory methodologies. The role emphasizes problem solving, regulatory compliance, and high-quality technical documentation.

The candidate will support execution of test plans, instrument qualification, and data analysis, leveraging cGMP knowledge and statistical methods to ensure validated methods meet quality standards for biopharmaceutical manufacturing.

Qualifications

• Bachelor's degree in biotechnology, microbiology, pharmacy, chemistry or equivalent.
• Minimum of 7 years of analytical development/validation experience in pharma/biopharma or related manufacturing.
• Knowledge of Life Cycle Validation documents and CGMP standards.
• Experience with paperless validation software for life science.
• Familiar with Commissioning, IQ/OQ/PQ protocols and reports for equipment/facilities/utilities.
• Knowledge of computer system validation (SCADA, MES).
• Knowledge of QC/micro lab instrument qualification and method validation.

Responsibilities

• Drive analytical method validation/ transfer of laboratory methodologies.
• Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols.
• Support troubleshooting of analytical methods.
• Ensure laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.
• Responsible for protocol and report generation and other technical documents as required. This may include supporting raw material qualification for new products.
• Use sound scientific principles and statistical techniques to solve problems and make recommendations.
• May Support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.

Skills

Analytical method validation

Transfer of laboratory methodologies

Statistical data analysis

Technical writing

cGMP knowledge

Regulatory compliance

Problem solving

Strategic thinking

Education

Bachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent

Advanced degree (preferred)

Tools

SCADA

MES

Validation software

Job description

Katalyst CRO in Thousand Oaks, CA invites a senior analytical development professional to drive method validation and transfer across laboratory methodologies. The role emphasizes problem solving, regulatory compliance, and high-quality technical documentation.

The candidate will support execution of test plans, instrument qualification, and data analysis, leveraging cGMP knowledge and statistical methods to ensure validated methods meet quality standards for biopharmaceutical manufacturing.