Job Description

Responsible for the validation of analytical methods—particularly ELISA-based potency assays—in full compliance with Good Manufacturing Practice (GMP) standards. This role ensures that methods are scientifically sound, robust, and suitable for their intended purpose. Additionally, the position plays a critical role in the successful transfer of validated methods, including those developed in R&D, into GMP laboratories for routine use.

Key Responsibilities

Design, execute, and document analytical method validation protocols for ELISA-based potency assays and other analytical techniques, following GMP and ICH guidelines.

Collaborate with R&D scientists to optimize and adapt ELISA methods for GMP applicability, ensuring readiness for validation and transfer.

Assess method performance characteristics, including specificity, accuracy, precision, linearity, range, and robustness to confirm suitability for GMP environments.

Generate detailed validation protocols, reports, and regulatory documentation to support audits and compliance inspections.

Lead and support the technical transfer of ELISA-based assays and other validated methods into GMP laboratories, including training, troubleshooting, and procedural implementation.

Work closely with cross-functional teams (Quality Assurance, QC, Manufacturing) to ensure seamless method adoption and ongoing compliance.

Investigate and resolve method-related deviations, participate in root cause analyses, and implement corrective actions as needed.

Leadership Responsibilities

Supports and monitors the performance of the team of employees

May participate in new hire interviews

Supports the onboarding process of new employees

Disseminate administrative communications

Demonstrate and promote the company's vision

Ensure adherence to the highest quality and efficiency standards in laboratory operations

Ensure coverage and performance for all shifts and work duties

Performs administrative tasks for team member growth and development

Adeptly balance technical lab work with leadership responsibilities