Chemist II

Job Description

Position Summary
We are seeking a highly motivated Chemist II to join our analytical laboratory team in Northridge, CA. In this role, you will support analytical testing, method development, validation, and troubleshooting activities for pharmaceutical and/or medical device products. The successful candidate will utilize advanced analytical instrumentation, ensure compliance with regulatory standards, and collaborate with cross-functional teams to deliver high-quality laboratory results.

This position is ideal for candidates with strong hands-on experience in chromatographic and spectroscopic techniques within a regulated laboratory environment.
Key Responsibilities

• Perform routine and non-routine chemical analyses using advanced analytical instrumentation.
• Develop, optimize, validate, and transfer analytical methods in accordance with ICH, USP, and internal procedures.
• Operate, troubleshoot, calibrate, and maintain analytical instruments including:
  • FTIR
  • ICP-MS
  • LC-UV/HPLC
  • LC-MS
  • GC-FID
  • GC-MS
• Prepare samples, reagents, calibration standards, and quality control solutions.
• Analyze raw data, interpret results, and prepare technical reports.
• Investigate laboratory deviations, out-of-specification (OOS), and out-of-trend (OOT) results.
• Document laboratory activities in accordance with GMP/GLP and data integrity requirements.
• Utilize laboratory software including LIMS and Empower for sample tracking, instrument control, and data management.
• Participate in laboratory investigations, root cause analysis, and corrective actions.
• Support stability studies, product characterization, verification, and validation activities.
• Prepare and review laboratory documentation including:
  • Test methods
  • Validation protocols
  • Validation reports
  • SOPs
  • Specifications
• Collaborate with Quality, Manufacturing, Regulatory Affairs, and R&D teams.
• Ensure compliance with FDA regulations, laboratory safety requirements, and company quality systems.
• Assist with continuous improvement initiatives to enhance laboratory efficiency and analytical performance.

Required Qualifications

• Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 2-5+ years of analytical laboratory experience in pharmaceutical, medical device, biotechnology, or related regulated industries.
• Strong hands-on experience with:
  • FTIR
  • ICP-MS
  • LC-UV/HPLC
  • LC-MS
  • GC-FID
  • GC-MS
• Experience with analytical method development and method validation.
• Experience working in a regulated laboratory environment (GMP, GLP, ISO, or FDA).
• Working knowledge of:
  • Microsoft Office Suite
  • LIMS
  • Waters Empower (preferred)
• Strong analytical, troubleshooting, and problem-solving skills.
• Excellent documentation and technical writing skills.
• Ability to manage multiple priorities while maintaining accuracy and attention to detail.
• Strong verbal and written communication skills.

EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Meet Your Recruiter

Christopher Raj