Apex Systems
Overview
The Analytical Laboratory Manager is responsible for overseeing all operations within the analytical laboratory, specializing in the testing of raw ingredients and finished products. This role manages routine analytical testing, method development and validation, and ensures compliance with cGMP, GLP, 21 CFR Part 111, and ISO 17025 standards. The position includes oversight of advanced analytical instrumentation, establishment and maintenance of quality systems, and enforcement of documentation and reporting practices in alignment with company policies and regulatory requirements. The Analytical Laboratory Manager also trains and supervises laboratory staff, ensuring technical proficiency, regulatory compliance, and the consistent delivery of accurate and reliable results to support product testing and quality assurance. Responsibilities
Method Development & Validation: Design, develop, optimize, and validate analytical methods for HPTLC, HPLC, and ICP-MS to support testing of botanical raw materials, active ingredients, and finished products Method Transfers, Troubleshooting, and Regulation: Implement method transfers, troubleshoot instrumentation, and ensure methods meet regulatory standards for accuracy, precision, sensitivity, and robustness Documentation: Author and review method SOPs, validation protocols, and technical reports Analytical Testing & Oversight: Supervise and perform qualitative and quantitative analysis using HPTLC, HPLC, ICP-MS, and FTIR Support Additional Techniques: Collaborate with microbiology teams on ELISA and microbial assays Stability, Purity, and Contaminants: Conduct stability, purity, and contaminant testing (heavy metals, pesticides, adulterants) Compliance & QA: Ensure all laboratory operations comply with cGMP, GLP, ISO 17025, and FDA regulations; oversee audits and CAPAs; maintain complete documentation of raw data and validation records Leadership & Team Development: Train, mentor, and supervise junior analysts and lab technicians; foster continuous improvement and cross-functional collaboration; drive efficiency and quality via best practices Laboratory Operations: Manage equipment qualification, calibration, preventive maintenance, inventory management, and safety/HSE compliance Qualifications
BS or MS in Chemistry, Biochemistry, or related field 5+ years in analytical laboratory testing, with at least 3 years in method development and validation for HPTLC, HPLC, and ICP-MS Strong technical expertise in analytical instrumentation, troubleshooting, and optimization Understanding of regulatory frameworks for company products; knowledge of ISO 17025 and accreditation audits (preferred) Excellent communication, leadership, and organizational skills Passion for scientific excellence and alignment with health and wellness values Benefits
Paid Time Off (PTO) Company-covered health, dental, and life insurance 5% 401(k) match plus an additional 4% Wellness Bonus for gym, continuing education, preventive care, and other reimbursements Employee store credit Company-sponsored events Fun team-building activities Equal Opportunity Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178
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The Analytical Laboratory Manager is responsible for overseeing all operations within the analytical laboratory, specializing in the testing of raw ingredients and finished products. This role manages routine analytical testing, method development and validation, and ensures compliance with cGMP, GLP, 21 CFR Part 111, and ISO 17025 standards. The position includes oversight of advanced analytical instrumentation, establishment and maintenance of quality systems, and enforcement of documentation and reporting practices in alignment with company policies and regulatory requirements. The Analytical Laboratory Manager also trains and supervises laboratory staff, ensuring technical proficiency, regulatory compliance, and the consistent delivery of accurate and reliable results to support product testing and quality assurance. Responsibilities
Method Development & Validation: Design, develop, optimize, and validate analytical methods for HPTLC, HPLC, and ICP-MS to support testing of botanical raw materials, active ingredients, and finished products Method Transfers, Troubleshooting, and Regulation: Implement method transfers, troubleshoot instrumentation, and ensure methods meet regulatory standards for accuracy, precision, sensitivity, and robustness Documentation: Author and review method SOPs, validation protocols, and technical reports Analytical Testing & Oversight: Supervise and perform qualitative and quantitative analysis using HPTLC, HPLC, ICP-MS, and FTIR Support Additional Techniques: Collaborate with microbiology teams on ELISA and microbial assays Stability, Purity, and Contaminants: Conduct stability, purity, and contaminant testing (heavy metals, pesticides, adulterants) Compliance & QA: Ensure all laboratory operations comply with cGMP, GLP, ISO 17025, and FDA regulations; oversee audits and CAPAs; maintain complete documentation of raw data and validation records Leadership & Team Development: Train, mentor, and supervise junior analysts and lab technicians; foster continuous improvement and cross-functional collaboration; drive efficiency and quality via best practices Laboratory Operations: Manage equipment qualification, calibration, preventive maintenance, inventory management, and safety/HSE compliance Qualifications
BS or MS in Chemistry, Biochemistry, or related field 5+ years in analytical laboratory testing, with at least 3 years in method development and validation for HPTLC, HPLC, and ICP-MS Strong technical expertise in analytical instrumentation, troubleshooting, and optimization Understanding of regulatory frameworks for company products; knowledge of ISO 17025 and accreditation audits (preferred) Excellent communication, leadership, and organizational skills Passion for scientific excellence and alignment with health and wellness values Benefits
Paid Time Off (PTO) Company-covered health, dental, and life insurance 5% 401(k) match plus an additional 4% Wellness Bonus for gym, continuing education, preventive care, and other reimbursements Employee store credit Company-sponsored events Fun team-building activities Equal Opportunity Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178
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