Supplement Testing Method Development Specialist

Job Title: Supplement Testing Method Development Specialist

Position Summary

The Supplement Testing Method Development Specialist is responsible for designing, developing, validating, and optimizing analytical methods for dietary supplement testing in compliance with federal and Florida regulatory requirements. This role ensures all laboratory methods meet scientific, quality, and compliance standards, supporting accurate, defensible results for products distributed within and from the State of Florida.

Key Responsibilities

Method Development & Validation

• Develop, optimize, and validate analytical testing methods for dietary supplements, including potency, identity, contaminants (heavy metals, pesticides, residual solvents), and microbiological analysis
• Establish and document method performance characteristics (accuracy, precision, specificity, linearity, range, robustness)
• Design and execute validation protocols in accordance with U.S. Food and Drug Administration requirements, United States Pharmacopeia, and AOAC International guidelines
• Troubleshoot and refine analytical methods to improve reliability, efficiency, and scalability

Regulatory & Compliance Alignment (Florida-Focused)

• Ensure all testing methods align with federal dietary supplement regulations under 21 CFR Part 111 (Current Good Manufacturing Practices)
• Support compliance with the Florida Department of Agriculture and Consumer Services for products manufactured, distributed, or tested in Florida
• Maintain readiness for inspections, audits, and regulatory reviews applicable within the State of Florida
• Ensure proper documentation and defensibility of methods in the event of regulatory inquiry or product investigation

Analytical Testing Support

• Perform advanced analytical testing using validated methods as needed
• Provide technical expertise to resolve complex testing challenges
• Evaluate and implement new instrumentation and technologies to enhance lab capabilities

Documentation & Data Integrity

• Author and maintain method SOPs, validation protocols, and technical reports in accordance with cGMP and data integrity standards (ALCOA principles)
• Ensure all documentation meets audit and legal defensibility standards
• Maintain traceability of method changes and validation history

Continuous Improvement

• Monitor method performance and implement improvements based on data trends
• Stay current on regulatory updates, particularly those impacting supplement testing in Florida
• Collaborate with quality and leadership teams to expand testing capabilities and improve turnaround times

Qualifications

Education & Experience

• Bachelor’s or Master’s degree in Chemistry, Biology, or related scientific field (required)
• 3 years of experience in analytical method development (dietary supplements, pharmaceuticals, food testing, or cannabis preferred)
• Experience working within cGMP-regulated environments required

Technical Skills

• Expertise in analytical instrumentation (HPLC, GC, LC-MS/MS, ICP-MS, etc.)
• Strong understanding of USP, AOAC, EAP and FDA method validation requirements
• Experience with stability-indicating methods and contaminant testing preferred

Core Competencies

• Strong analytical thinking and problem-solving skills
• High attention to detail with a focus on data integrity and compliance
• Ability to manage multiple method development projects simultaneously
• Strong technical writing and documentation skills

Key Success Metrics

• Successful development and validation of compliant, robust analytical methods
• Audit and inspection readiness (FDA and Florida regulatory bodies)
• Reduction in method variability and testing errors
• Timely implementation of new and improved testing methodologies

Certifications, Licenses, Registrations:

None

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prolonged periods of sitting at a desk and working on a computer, walking/moving around and standing, talking and hearing and using hands to handle, control or feel objects, tools or controls
• Occasional periods of stooping/kneeling, bending
• Close vision and ability to focus on computer screens and documents; distance vision; peripheral vison; depth perception; color vision

Mental Requirements:

The mental demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The ability to learn new tasks, remember processes, and maintain focus.
• Complete tasks independently, make timely decisions in the context of a workflow.
• The ability to communicate effectively with internal and external members of the operation.
• The ability to complete tasks in situations that have a speed or productivity quota.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The employee works in a laboratory environment.

While performing work-related duties the employee occasionally works with hazardous, toxic or caustic chemicals such as acids and solvents, works around fumes or airborne particles from laboratory chemicals used/fume hoods works with or near moving mechanical parts from laboratory equipment and works with equipment that vibrates. The noise level in the work environment is usually moderate.

Work Schedule:

• 40 hours, Monday through Friday
• May require on-call duty and the ability to work outside of scheduled work hours including weekends and holidays when the need arises
• Some travel during the day and overnight, 10% - to other laboratories, attend seminars, training and/or conferences

Pay: $65,000.00 - $72,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $65,000 - $72,000