QC Specialist: Analytical Method Validation and Transfer

What You'll Do

• Lead the validation, qualification, verification, and lifecycle management of analytical methods supporting biologic drug substance and drug product testing.
• Serve as the technical lead for analytical method transfers to internal laboratories, contract testing laboratories (CTLs), and regulatory affiliates, ensuring successful demonstration of method equivalency and readiness for routine testing.
• Author and review method transfer plans, protocols, gap assessments, risk assessments, statistical evaluations, and final transfer reports.
• Provide technical expertise, training, troubleshooting, and hands-on support during method validation and transfer activities to ensure successful implementation at receiving laboratories.
• Collaborate with Analytical Development, Quality Assurance, Regulatory Affairs, and external partners to support product development, commercialization, and post-approval lifecycle activities.
• Ensure analytical methods, specifications, reagents, standards, and testing procedures are compliant with applicable GMP, health authority, and regional regulatory requirements.
• Investigate method transfer failures, atypical results, deviations, OOS/OOT events, and analytical discrepancies, implementing effective corrective and preventive actions as needed.

Education & Experience Requirements

• Bachelor's degree or equivalent in Biochemistry, Biology, Biotechnology, Microbiology, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years') or equivalent combination of education, training, & experience.

Qualifications

• Demonstrated experience leading analytical method validation, qualification, verification, and transfer activities for biologic drug substance and drug product programs.
• Experience authoring and reviewing validation and transfer protocols, reports, technical assessments, and GMP documentation.
• Experience supporting global testing networks, including contract testing laboratories (CTLs), CDMOs, and in-country testing laboratories.

Preferred Qualifications

• Strong understanding of cGMP, ICH, USP, EP, JP, and applicable global regulatory requirements governing analytical testing and method validation.
• Hands-on experience with biologics analytical techniques such as HPLC/UPLC, CE-SDS, icIEF, ELISA, and cell-based potency assays.
• Strong knowledge of analytical method validation principles, statistical analysis, comparability assessments, and method transfer strategies.