QC Chemist

Seeking an Analytical Chemist to join a highly respected pharmaceutical contract development and manufacturing organization (CDMO) in the Horsham, Pennsylvania area. This privately held organization has over three decades of success supporting leading global pharmaceutical companies and is recognized for its exceptional quality standards, strong regulatory history, and investment in advanced laboratory technology. The company offers a collaborative environment where scientists work directly with clients on innovative drug development programs spanning early-stage development through commercial manufacturing.

Responsibilities

• Perform analytical testing of raw materials, in-process samples, stability samples, and finished pharmaceutical products.
• Execute method development, method transfer, validation, and analytical troubleshooting activities.
• Operate and maintain analytical instrumentation, including:
  • HPLC/UHPLC
  • Dissolution systems
  • ICP-MS
  • UV/Vis Spectrophotometers
  • Gas Chromatography (GC)
  • Karl Fischer
  • Malvern particle size analyzers and other laboratory instrumentation
• Conduct second analyst reviews to ensure data accuracy and integrity.
• Review laboratory documentation, analytical data, protocols, and reports for compliance with cGMP, USP, ICH, and FDA regulations.
• Support stability studies, equipment calibration, and routine laboratory maintenance.
• Collaborate with cross-functional teams and interact with clients to support project timelines.
• Participate in continuous improvement initiatives with a strong focus on prevention, quality by design (QbD), and operational excellence.
• Utilize electronic laboratory systems, including LIMS and electronic laboratory notebooks.

Qualifications

• Bachelor's degree in Chemistry, Chemical Engineering, or similar field.
• Minimum of 5 years of pharmaceutical analytical laboratory experience; 10+ years preferred.
• Experience working within a cGMP pharmaceutical laboratory.
• Hands-on experience with HPLC/UHPLC, dissolution testing, and other analytical instrumentation.
• Proven experience with method development, method validation, and analytical troubleshooting.
• Working knowledge of FDA, USP, ICH, and 21 CFR regulatory requirements.
• Experience supporting regulatory inspections, client audits, and second reviewer responsibilities is highly desirable.