Senior Analytical Method Developer (ISO 17025, GMP)

Socket.dev; Henderson (NV); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive medical/dental/vision

Paid time off

401(k) with company match

Life and disability coverage

Gym membership

HSA/vitamin allowance

Referral program

Pet insurance

Job summary

ProCaps is seeking a Quality Control Method Development Specialist to lead analytical method development, validation, and transfer in support of ISO/IEC 17025 accreditation and cGMP compliance.

You will oversee method development across HPLC, GC, ICP-MS, UV/Vis, HPTLC, and Protein Analyzer platforms, collaborating with QC Operations, Product Development, and QA to ensure scientifically sound, compliant methods and data integrity.

Qualifications

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

Responsibilities

• Develop, optimize, implement, and troubleshoot analytical methods for raw materials, in-process materials, finished products, stability programs, and new product formulations.
• Adapt USP, AOAC, customer, regulatory, and published methods for existing laboratory instrumentation and applications.
• Design and execute method validation, verification, transfer, equivalency, and performance studies.
• Prepare validation protocols, reports, technical assessments, and supporting documentation while maintaining validation master plans and roadmaps.
• Establish scientifically justified acceptance criteria and validation parameters.
• Lead the implementation, qualification, verification, and integration of new analytical instrumentation and technologies.
• Develop methodologies and procedures for emerging technologies, including HPTLC and Protein Analyzer platforms.
• Identify and implement opportunities to improve testing efficiency, accuracy, throughput, and automation.
• Serve as the laboratory subject matter expert for analytical methods, instrumentation, data interpretation, and technical troubleshooting.
• Provide technical support, training, competency development, mentoring, and problem-solving guidance to laboratory personnel.
• Lead technical assessments and investigations related to OOS, OOT, atypical results, and laboratory nonconformances.
• Support root cause analyses, CAPA development, analytical data reviews, trend evaluations, and continuous method improvement.
• Ensure method development, validation, and laboratory activities comply with ISO/IEC 17025, cGMP, data integrity, and applicable regulatory requirements.
• Support audits, accreditation assessments, regulatory inspections, internal audits, and maintain audit-ready documentation.
• Drive quality system improvements by reducing validation backlogs, improving laboratory performance metrics, enhancing method robustness and efficiency, supporting timely investigations, and contributing to continuous audit readiness and compliance.

Education

Bachelor's degree in chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or another natural or physical science

Tools

HPLC systems

GC systems

ICP-MS

HPTLC

UV/VIS instruments

Protein Analyzer

Job description

ProCaps is seeking a Quality Control Method Development Specialist to lead analytical method development, validation, and transfer in support of ISO/IEC 17025 accreditation and cGMP compliance.

You will oversee method development across HPLC, GC, ICP-MS, UV/Vis, HPTLC, and Protein Analyzer platforms, collaborating with QC Operations, Product Development, and QA to ensure scientifically sound, compliant methods and data integrity.