Analytical Chemist II

KVK Tech is seeking an experienced Analytical Chemist II to join our team in Newtown, PA.

The Analytical Chemist II will independently perform analytical testing and support method development, validation, and technical transfer activities for oral solid dosage pharmaceutical products. This role plays a critical part in ensuring data integrity, regulatory compliance, and high‑quality analytical output in support of product development and lifecycle management. The ideal candidate will demonstrate strong chromatographic expertise, sound scientific judgment, and the ability to mentor junior laboratory staff within a cGMP‑regulated environment.

• Independently perform analytical testing of raw materials, intermediates, stability samples, and finished products using HPLC/UPLC, GC, dissolution, UV‑Vis, and related techniques.
• Support and execute analytical method development, optimization, verification, transfer, and validation activities in accordance with ICH, USP, and FDA expectations.
• Operate, calibrate, and troubleshoot analytical instrumentation, coordinating routine and preventive maintenance to ensure instrument readiness and compliance.
• Review, interpret, and trend analytical data to identify atypical results, support investigations, and implement scientifically justified corrective actions.
• Document laboratory activities in compliance with cGMP, FDA regulations (21 CFR 210/211), ICH guidelines, and internal data integrity requirements.
• Provide technical guidance, training, and mentorship to junior analytical staff while contributing to departmental continuous improvement initiatives.

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related scientific discipline required;
  Master’s degree preferred.
• Minimum of 2–5 years of analytical laboratory experience in a cGMP‑regulated pharmaceutical, biotechnology, or contract laboratory environment.
• Demonstrated hands‑on proficiency with HPLC/UPLC; experience with GC, dissolution testing, and wet chemistry techniques preferred.
• Working knowledge of cGMP, GLP, FDA regulations, ICH guidelines, and ALCOA+ data integrity principles.
• Strong technical writing, organizational, and communication skills with the ability to manage multiple priorities in a deadline‑driven environment.

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays

KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status. We encourage you to apply if you feel that you are a match! We look forward to hearing from you. Apply for this position