Analytical Chemist Cleaning Validation Support

Availability: Willingness to travel and spend at least 1 month on-site in South Korea.
Location: Primarily remote (US Based), with approximately 1 month on-site in South Korea to oversee cleaning swab recovery studies. Travel: All travel and project-related expenses covered in accordance with client policies.
Visa: No visa required for 30-day stay for U.S. citizens and s.

Position Overview

We are looking for a highly skilled Quality Control Subject Matter Expert (QC SME) to support a cleaning validation project for small-molecule biopharmaceutical manufacturing. This role is ideal for an experienced analytical chemist with hands-on expertise in LC-MS, HPLC, TOC, and cleaning verification studies. The selected candidate will play a critical role in designing, executing, and documenting cleaning swab recovery studies, collaborating closely with on-site teams in South Korea, and ensuring compliance with global regulatory standards.

Key Responsibilities

Design and execute cleaning swab recovery studies for small-molecule products, using representative surrogates and cytotoxic payloads based on existing template protocols.
Apply analytical methods (LC-MS, HPLC, TOC) for swab analysis and cleaning verification.
Qualify surrogate compounds following USP/EU compendial test methods for use in cleaning validation programs.
Prepare and review documentation including protocols, reports, and supporting data in alignment with FDA, EMA, and PIC/S expectations.
Collaborate with cross-functional teams in South Korea to support laboratory and validation activities on-site.
Provide remote support for protocol development, technical review, and report writing throughout the duration of the project.

Qualifications

Education: B.S., M.S., or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field (advanced degree preferred).
Experience: 5+ years in analytical method validation and cleaning verification within a GMP-regulated environment.
Technical Expertise: Demonstrated hands-on experience with LC-MS, HPLC, TOC, and swab recovery studies.
Regulatory Knowledge: Familiarity with FDA, EMA, ICH, and PIC/S cleaning validation requirements.
Soft Skills: Excellent technical writing, documentation, and communication skills.