Develops scientifically valid testing methods for incoming raw materials and products to meet qualitative and quantitative claims for active ingredients/strength markers. Writes standard operating procedures, white papers, justifications, investigations, and testing methods in compliance with company policies, procedures, and cGMPs. Performs lab work and reference searches in analytical chemistry, chemistry, and biochemistry to facilitate product analyses and development. Provides training and mentoring to QC analytical laboratory staff and junior method development scientists. Executes method transfers to QC labs on-site and at satellite locations. Verifies, adopts, and applies official analytical methods (e.g., AOAC, USP) and other published methods to raw materials and finished products. Troubleshoots and solves technical problems during innovative analytical methods development and regular QC testing. Develops procedures for separating and isolating active components and/or strength markers for use as reference standards. Obtains information about natural products and their analytical determination procedures from scientific literature, conferences, seminars, and the Internet. Develops procedures for potential savings and increased efficiency in new and current testing methodologies. Evaluates new analytical instrumentation and makes recommendations to management regarding capital expenditures. Presents papers, abstracts, and presentations at scientific meetings, customer conferences, tours, etc. Complies with safety and GMP requirements. Supports a culture of safe laboratory and production operations; follows all safety rules and procedures. Actively participates in the safety program by engaging in training activities, reporting safety concerns, submitting safety suggestions, and correcting or reporting workplace health or safety hazards. Assists with communicating safety information to new employees. Fulfills responsibilities as outlined in the company safety management plan.
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Job Type
Full-time
Career Level
Mid Level