Senior QC Chemist — Analytical Method Leader (Pharma)

KVK Tech, Inc.; Newtown Township (Delaware County); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401(k) with company match

Health, vision, and dental Insurance

Annual merit increases

Paid Time Off and Flexible Holidays

Job summary

KVK Tech, Inc. seeks an accomplished QC Chemist III in Newtown, PA to serve as a senior analytical scientist in the Quality Control lab supporting oral solid dosage manufacturing.

The role independently performs advanced testing (HPLC/UPLC/GC/UV-Vis), leads method validation and transfers, troubleshoots complex issues, reviews data, and mentors junior chemists while ensuring Data Integrity and regulatory compliance.

Qualifications

• Bachelor’s degree in Chemistry or related field required; Master’s preferred.
• 6+ years of progressive analytical lab experience in a cGMP pharma QC/analytical-development environment.
• Advanced proficiency with HPLC and complementary techniques (UPLC, GC, UV-Vis, dissolution, Karl Fischer).
• Experience leading/performing method validation, verification, and transfer and solving instrument issues.
• Experience reviewing GMP analytical data and supporting investigations, CAPAs, and change controls.
• Strong knowledge of cGMP, GLP, ICH Q2(R2), USP, 21 CFR Parts 11 and 211; data integrity expectations.

Responsibilities

• Perform and oversee advanced analytical testing using HPLC, UPLC, GC, UV-Vis, dissolution, Karl Fischer titration, and other validated methods.
• Lead or execute analytical method validation, verification, and transfer activities with proper documentation.
• Evaluate complex analytical results, identify trends, and support OOS/OOT investigations and CAPAs.
• Review and approve laboratory data, calculations, and chromatographic results for accuracy and data integrity.
• Qualify, calibrate, and maintain laboratory instrumentation; author protocols and SOPs.
• Provide technical guidance and mentorship to junior chemists and support cross-functional problem-solving.

Skills

Analytical leadership

Mentoring

Regulatory knowledge

Data Integrity

Scientific writing

Communication

Education

Bachelor’s degree in Chemistry

Master’s degree in Chemistry or Analytical Chemistry

Tools

HPLC

UPLC

GC

UV-Vis

Dissolution

Karl Fischer titration

Empower

LIMS

Job description

KVK Tech, Inc. seeks an accomplished QC Chemist III in Newtown, PA to serve as a senior analytical scientist in the Quality Control lab supporting oral solid dosage manufacturing.

The role independently performs advanced testing (HPLC/UPLC/GC/UV-Vis), leads method validation and transfers, troubleshoots complex issues, reviews data, and mentors junior chemists while ensuring Data Integrity and regulatory compliance.