Lead Analytical Method Validation Scientist - cGMP

Katalyst CRO; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO in Thousand Oaks, CA is seeking a senior analytical development professional to lead method validation and transfer across laboratory methodologies. You will tackle complex problems, ensure regulatory compliance, and deliver high-quality technical documentation to support biopharmaceutical manufacturing.

The role involves supporting test plans, instrument qualification, and data analysis, applying cGMP principles and statistical methods to ensure validated methods meet quality

Qualifications

• Experience in analytical development and validated method transfers.
• Strong data analysis and statistical skills.
• Working knowledge of cGMP and regulatory expectations.
• Excellent technical documentation abilities.

Responsibilities

• Drive method validation and transfer across lab methodologies.
• Support execution of test plans and instrument qualification.
• Ensure validated methods meet quality standards and regulatory requirements.

Skills

Analytical development

Method validation

Transfer of methods

Data analysis

cGMP knowledge

Regulatory compliance

Technical documentation

Tools

Instrument qualification

Job description

Katalyst CRO in Thousand Oaks, CA is seeking a senior analytical development professional to lead method validation and transfer across laboratory methodologies. You will tackle complex problems, ensure regulatory compliance, and deliver high-quality technical documentation to support biopharmaceutical manufacturing.

The role involves supporting test plans, instrument qualification, and data analysis, applying cGMP principles and statistical methods to ensure validated methods meet quality