Analytical Laboratory Manager

Analytical Laboratory Manager

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

- Implement method transfers, troubleshoot instrumentation, and ensure methods meet regulatory standards for accuracy, precision, sensitivity, and robustness

- 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 testing techniques (e.g., ELISA, microbial assays) in collaboration with microbiology teams

- Conduct stability, purity, and contaminant testing (heavy metals, pesticides, adulterants).

Compliance & Quality Assurance

- Ensure all laboratory operations comply with cGMP, GLP, ISO 17025, and FDA regulations

- Oversee audit readiness, participate in internal and external audits, and implement CAPAs

- Maintain accurate and complete documentation of all raw data, reports, and validation records

Leadership & Team Development

- Train, mentor, and supervise junior analysts and lab technicians

- Foster a culture of continuous improvement, technical excellence, and cross-functional collaboration

- Drive efficiency and quality by implementing best practices in analytical workflows

Laboratory Operations

- Manage equipment qualification, calibration, and preventive maintenance schedules

- Oversee inventory management and ensure availability of critical reagents, standards, and consumables

- Uphold laboratory safety standards and compliance with all EH&S policies

Education and Skills

- BS or MS degree in Chemistry, Biochemistry, or a related scientific field

- 5+ years of experience 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.

- In-depth understanding of regulatory frameworks for company products

- Knowledge of ISO 17025 standards and experience with accreditation audits (preferred)

- Excellent communication, leadership, and organizational skills

- Passion for scientific excellence and a lifestyle aligned 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, preventative care, and other reimbursements

- Employee store credit

- Company-sponsored events

EEO 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 have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178