Test Method Transfer and Qualification Scientist

Eliquent Life Sciences, Inc

8d

About The Position

The Test Method Transfer and Qualification Scientist plays a critical role in ensuring the successful transfer and validation of analytical test methods across manufacturing sites and laboratories within the organization. This position is responsible for designing, executing, and documenting method transfer protocols and qualification activities to guarantee that analytical methods perform consistently and reliably in new environments. The scientist collaborates closely with cross-functional teams including R&D, quality assurance, and manufacturing to support product development and commercial manufacturing processes. By ensuring robust and compliant analytical methods, this role directly contributes to product quality, regulatory compliance, and operational efficiency. Ultimately, the scientist helps to maintain high standards of testing accuracy and reproducibility, which are essential for delivering safe and effective products to market.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• At least 5 years of experience in analytical method development, transfer, or validation within a manufacturing or pharmaceutical environment.
• Strong understanding of analytical techniques such as HPLC, GC, spectroscopy, and wet chemistry methods.
• Familiarity with regulatory requirements and guidelines related to method validation and transfer (e.g., FDA, ICH).
• Proven ability to document and communicate scientific data clearly and effectively.

Nice To Haves

• Master’s degree or higher in a relevant scientific field.
• Experience working in a GMP-regulated environment within the pharmaceutical or biotechnology industry.
• Hands-on experience with statistical analysis software and data trending tools.
• Knowledge of quality systems and experience supporting regulatory inspections or submissions.
• Strong project management skills and experience coordinating cross-functional teams.

Responsibilities

• Develop and execute detailed test method transfer plans and qualification protocols to support the implementation of analytical methods at new sites or laboratories.
• Perform method validation and qualification experiments, analyze data, and prepare comprehensive reports documenting the transfer and qualification outcomes.
• Collaborate with R&D, quality control, manufacturing, and regulatory teams to ensure alignment on method requirements and compliance with industry standards and regulatory guidelines.
• Troubleshoot and resolve technical issues related to method transfer and qualification, providing scientific expertise and recommendations for corrective actions.
• Maintain accurate and thorough documentation in accordance with Good Manufacturing Practices (GMP) and company quality systems to support regulatory submissions and audits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level