ICP-MS Specialist /Analytical Chemist

Job Title: ICP-MS Specialist /Analytical Chemist

Department: Quality Control / Analytical Development

Reports to: Director of Analytical Sciences

Location: Mesa, AZ

Position Type: Full-time, Exempt

Job Summary:

We are seeking an experienced ICP-MS Specialist to lead elemental impurity testing and method development for our pharmaceutical manufacturing facility. This role will establish and maintain ICP-MS analytical capabilities supporting API development, raw material testing, and ICH Q3D compliance. The ideal candidate will develop analytical methods, validate protocols, and collaborate with cross-functional teams to ensure product quality and regulatory compliance.

Key Responsibilities:

• Develop and validate ICP-MS methods for elemental impurity analysis in APIs, intermediates, raw materials, and drug products according to USP <232>/<233> and ICH Q3D guidelines
• Perform routine and non-routine elemental analysis using ICP-MS, including sample preparation, instrument operation, and data analysis
• Maintain and troubleshoot ICP-MS instrumentation, including preventive maintenance, calibration, and performance verification
• Prepare technical documents including analytical methods, validation protocols, test reports, and regulatory submissions (DMF, NDA, ANDA sections)
• Conduct risk assessments for elemental impurities in pharmaceutical products and manufacturing processes
• Manage elemental impurity testing for multiple products including lidocaine and carboplatin manufacturing streams
• Collaborate with Process Development to identify and resolve elemental contamination sources
• Establish and maintain databases for trending elemental impurity results across products and raw materials
• Train laboratory personnel on ICP-MS operation and elemental analysis techniques
• Interface with QA to ensure GMP compliance and support regulatory inspections
• Partner with data science team to develop predictive models for elemental impurity control
• Support technology transfer and scale-up activities from development to commercial manufacturing

Required Qualifications:

• Bachelor's degree in Chemistry, Analytical Chemistry, or related field; Master's degree preferred
• Minimum 1-5 years hands-on experience with ICP-MS in a pharmaceutical or regulated environment
• Demonstrated experience in method development and validation for trace metals analysis
• Strong understanding of ICH Q3D, USP <232>/<233>, and pharmaceutical GMPs
• Experience with sample preparation techniques including microwave digestion and acid dissolution
• Proficiency in data analysis software and LIMS systems
• Knowledge of collision/reaction cell technology for interference removal
• Experience writing technical documents, SOPs, and regulatory submissions
• Strong problem-solving and troubleshooting skills

Preferred Qualifications:

• Advanced degree (MS/PhD) in Analytical Chemistry or related field
• 2+ years ICP-MS experience specifically in pharmaceutical applications
• Experience with continuous manufacturing or flow chemistry applications
• Knowledge of additional analytical techniques (ICP-OES, AAS, XRF)
• Experience with statistical analysis and chemometrics
• Familiarity with 21 CFR Part 11 compliance for computerized systems
• Programming skills (Python, R, VBA) for data analysis and automation
• Published research or presentations on elemental analysis or pharmaceutical applications
• Experience with method transfer and multi-site analytical support
• Knowledge of catalyst residue analysis in API manufacturing

Working Conditions:

• Laboratory environment with exposure to chemical reagents and samples
• Must be able to wear required PPE including lab coat, safety glasses, and gloves
• Occasional overtime and weekend work to support production schedules

Compensation:

• Disclosed during interview process

About Our Facility:

We operate state-of-the-art continuous flow manufacturing using proprietary STT (Spinning Tube Technology) reactors. Our analytical laboratory supports both commercial production and development activities for generic and novel APIs. Recent investment in ICP-MS capability represents our commitment to analytical excellence and quality leadership.

Equal Opportunity Statement:

We are an Equal Opportunity Employer committed to building a diverse and inclusive team.

To Apply:

Please submit your resume and cover letter highlighting your ICP-MS experience and interest in pharmaceutical analytical development. Include "ICP-MS Specialist" in the subject line.