Clark & Enersen · 9 hours ago
Test Method Transfer and Qualification Scientist
US
Full-time
Onsite
Senior Level
$60/hr - $70/hr
5+ years expClark & Enersen is a leading global consulting group specializing in regulatory affairs and quality compliance for life sciences companies. The Test Method Transfer and Qualification Scientist is responsible for ensuring the successful transfer and validation of analytical test methods across manufacturing sites, collaborating with cross-functional teams to support product development and maintain compliance with regulatory standards.
Consulting
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
Qualification
Required
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
Preferred
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
Company
Clark & Enersen
Clark & Enersen was founded in 1946 in by Architect Kenneth B. Clark and Landscape Architect Lawrence A.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase