Lead Analytical Method Development & Validation Scientist

ProCaps Laboratories; Henderson (NV); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Medical, dental, vision

Paid time off

401(k) with company match

Career growth opportunities

Job summary

ProCaps Laboratories seeks a Quality Control Method Development Specialist to provide technical leadership for analytical method development, validation, verification, and transfer activities in support of ISO/IEC 17025 accreditation and cGMP compliance.

You will serve as the laboratory SME for analytical methodologies and instrumentation, including HPLC, GC, ICP-MS, HPTLC, UV/Vis, and Protein Analyzer, collaborating with Quality Control Operations and other stakeholders to ensure methods are

Qualifications

• Bachelor's degree in chemistry or related science.
• 3+ years of experience in analytical method development, validation, or laboratory quality control.
• Experience with analytical method development and validation.
• Experience working in a regulated laboratory environment.
• Strong understanding of analytical chemistry principles and investigations.
• Proficiency with Microsoft Office.
• Experience with HPLC, GC, ICP-MS, UV/Vis, HPTLC or similar instrumentation.
• Familiar with USP, AOAC, ICH, ISO/IEC 17025 and related bodies.

Responsibilities

• Develop, optimize, validate, verify, and transfer analytical methods for materials and products.
• Adapt USP, AOAC, regulatory, and published methods for existing instruments and applications.
• Design and execute method validation, verification, transfer, and performance studies.
• Prepare validation protocols, reports, and supporting documentation while maintaining validation master plans.
• Establish acceptance criteria and validation parameters.
• Lead implementation and integration of new instrumentation and technologies.
• Develop methodologies for emerging technologies including HPTLC and Protein Analyzer platforms.
• Identify opportunities to improve testing efficiency, accuracy, throughput, and automation.
• Serve as SME for analytical methods, instrumentation, data interpretation, and troubleshooting.
• Provide technical support, training, mentoring, and problem-solving to laboratory personnel.
• Lead investigations related to OOS, OOT, atypical results, and nonconformances.
• Support root cause analyses, CAPA, data reviews, trend evaluations, and continuous improvement.
• Ensure compliance with ISO/IEC 17025, cGMP, data integrity, and regulatory requirements.
• Support audits, accreditation assessments, inspections, and maintain audit-ready docs.
• Drive quality system improvements by reducing backlogs and enhancing method robustness.

Skills

Analytical method development

Method validation

Laboratory quality control

Regulated environment

HPLC

GC

ICP-MS

HPTLC

UV/Vis

Protein Analyzer

ISO/IEC 17025

ICH guidelines

USP AOAC

cGMP

Data integrity

Education

Bachelor's degree in Chemistry

Tools

Microsoft Office

Job description

ProCaps Laboratories seeks a Quality Control Method Development Specialist to provide technical leadership for analytical method development, validation, verification, and transfer activities in support of ISO/IEC 17025 accreditation and cGMP compliance.

You will serve as the laboratory SME for analytical methodologies and instrumentation, including HPLC, GC, ICP-MS, HPTLC, UV/Vis, and Protein Analyzer, collaborating with Quality Control Operations and other stakeholders to ensure methods are