Analytical Chemist - Cleaning Validation Support

VTI Life Sciences

8d • Remote

About The Position

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry. We are seeking an experienced Quality Control Subject Matter Expert (QC SME) to support a project focused on cleaning validation for small-molecule biopharmaceutical manufacturing. The role requires expertise in analytical methods such as LC-MS, HPLC, and TOC, as well as cleaning verification laboratory studies using industry-standard techniques. All project-related expenses will be covered in accordance with the client’s policies. Contract Position: Analytical Chemist– Cleaning Validation Support Duration: 4 - 5 months Location: Primarily remote, with at least 1 month on-site in South Korea to oversee execution of cleaning swab recovery protocols. o All expenses paid o Strong writing and communication skills o No VISA required for 30-day stay (1 month) for USA citizens and green card holders

Requirements

• An advanced degree (B.S., M.S., or Ph.D.) in Analytical Chemistry, Pharmaceutical Sciences, or a related field is preferred.
• 5+ years of experience in analytical method validation and cleaning verification.
• Proven hands-on experience with LC-MS, HPLC, and TOC testing.
• Direct experience with swab recovery studies for cleaning validation.
• Familiarity with global regulatory guidelines (FDA, EMA, ICH, PIC/S).
• Strong technical writing and documentation skills.
• Availability to travel and work onsite in South Korea for at least one month during the assignment.

Responsibilities

• Design and execute cleaning swab recovery studies for small-molecule products using a representative surrogate and cytotoxic payload, following existing template protocols.
• Understand analytical test methods such as LC-MS, HPLC, and TOC for swabs.
• Qualify representative surrogate compounds using USP/EU Compendial test methods for cleaning validation programs.
• Generate and review protocols, reports, and supporting documentation using client template protocols and report formats that align with FDA, EMA, and PIC/S expectations.
• Collaborate with site teams in South Korea to conduct onsite laboratory and validation activities.
• Provide remote technical support for protocol development and summary report writing, and support the execution of swab and recovery studies onsite.

Benefits

• VTI offers professional development, training, competitive compensation, excellent benefits, matching 401K, plus a stimulating and collaborative work environment.
• We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees.

What This Job Offers

• Career Level: Mid Level
• Number of Employees: 51-100 employees