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Analytical Chemist / QC Laboratory Manager MitWellness Independence, MO Job Details Full-time $85,000 - $110,000 a year 19 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Employee discount Life insurance Retirement plan Qualifications Regulatory documents Laboratory equipment performance testing and validation High-performance liquid chromatographs Laboratory instrument validation Process improvement Equipment troubleshooting Good documentation practices (GDP) Technical report writing Laboratory equipment calibration Master's degree Manufacturing standard operating procedures Laboratory reports Bachelor's degree Laboratory standard operating procedures Compliance documentation Verification of laboratory test methods Technical troubleshooting support Training & development Chemical testing Test validation method Standard operating procedures (SOPs) Validation design FDA regulations Scientific reports Full Job Description

MITWELLNESS

Senior Analytical Chemist / QC Laboratory Manager Botanical Alkaloids, Kavalactones & In-House Microbiology Company TNT Manufacturing LLC dba MitWellness Location Kansas City metropolitan area Employment Type Full-time, on-site Department Quality Assurance / Quality Control Reports To Director of Quality and Executive Leadership Compensation $85,000-$110,000 base salary, depending on experience; bonus and benefits may be offered Position Summary MitWellness is seeking a highly capable analytical chemist to lead and expand our internal quality-control laboratory. This position is designed for a hands-on scientist who can independently operate and troubleshoot HPLC systems, develop and validate analytical methods, quantify kratom alkaloids and kava kavalactones, perform in-house microbiological testing, and support a growing botanical manufacturing operation. The successful candidate will be integrated into the QA/QC team and will contribute to raw-material qualification, in-process testing, finished-product release, method validation, stability programs, laboratory investigations, manufacturing optimization, third-party laboratory oversight, and regulatory documentation. This is not a routine sample-injection role. The position requires scientific judgment, strong documentation skills, and the ability to build laboratory systems that can withstand customer, regulatory, and GMP scrutiny. Primary Responsibilities1. HPLC Alkaloid and Kavalactone Testing

• Operate, maintain, and troubleshoot

HPLC-DAD/UV

systems for botanical and finished-product testing.

• Quantify mitragynine, 7-hydroxymitragynine, speciociliatine, speciogynine, paynantheine, mitragynine pseudoindoxyl, MGM-15, total alkaloids, and other targeted compounds as methods and standards allow.
• Develop and perform quantitative testing for the major kavalactones and evaluate kavalactone profiles, chemotypes, ratios, and total kavalactone content.
• Test raw botanicals, extracts, intermediates, capsules, powders, liquid shots, beverage concentrates, suspensions, and finished products.
• Review chromatograms for integration quality, peak identity, retention-time consistency, interference, carryover, degradation products, and atypical results. 2. Analytical Method Development, Validation, and Transfer
• Develop, optimize, qualify, validate, and document analytical methods for kratom alkaloids, kavalactones, and other botanical actives.
• Establish calibration models, system-suitability criteria, sample-extraction procedures, dilution schemes, and acceptance criteria.
• Perform accuracy, precision, recovery, specificity, selectivity, linearity, range, robustness, carryover, LOD, LOQ, and solution-stability studies.
• Evaluate matrix effects across powders, capsules, emulsions, beverages, extracts, and high-concentration formulations.
• Prepare method-validation protocols, reports, controlled methods, analyst worksheets, and method-transfer packages for contract laboratories. 3. In-House Microbiology Testing
• Establish and perform routine in-house microbiological testing appropriate for botanical ingredients and finished products.
• Conduct or oversee aerobic plate count, yeast and mold, coliform, and other indicator-organism testing using validated or compendial methods.
• Support pathogen screening workflows for organisms such as Salmonella and E. coli, while recognizing when confirmation or specialized testing must remain with an accredited outside laboratory.
• Prepare media, standards, controls, dilutions, environmental samples, and incubation records in accordance with controlled procedures.
• Perform growth-promotion, negative-control, positive-control, method-suitability, recovery, and inhibition studies as appropriate.
• Manage incubators, autoclaves or sterilization equipment, colony counters, biosafety equipment, temperature logs, culture controls, and microbiology laboratory supplies.
• Develop environmental-monitoring and sanitation-verification programs for production areas, laboratory areas, water systems, and critical surfaces.
• Investigate microbiological excursions, contamination events, objectionable-organism concerns, and recurring environmental trends.
• Maintain appropriate segregation, aseptic technique, waste handling, decontamination, and biosafety practices. 4. Raw Material, In-Process, and Finished-Product Control
• Support identity, potency, purity, strength, composition, and contaminant specifications for incoming materials and finished products.
• Compare supplier COAs against internal results and identify unexplained lot-to-lot variability or potential adulteration.
• Establish in-process sampling plans and test extraction fractions, blends, intermediates, and production holds.
• Perform or support blend-uniformity, content-uniformity, top-middle-bottom sampling, fill-weight correlation, mixing-time, sedimentation, and redispersion studies.
• Provide analytical data supporting batch release, rejection, reprocessing, and deviation decisions while maintaining appropriate Quality Unit independence. 5. Manufacturing and Process Development Support
• Track extraction efficiency, process recovery, active-component losses, solvent partitioning, filtration losses, drying losses, and batch-to-batch yield.
• Support process optimization involving pH, temperature, extraction time, solvent ratios, mixing, filtration, concentration, and drying.
• Assist with scale-up from development batches to commercial production.
• Use analytical data to identify manufacturing trends and opportunities to improve yield, consistency, and cost. 6. Stability, Shelf-Life, and Packaging Studies
• Design and manage real-time and accelerated stability programs.
• Monitor potency, degradation products, pH, precipitation, sedimentation, color, odor, moisture, microbial condition, and packaging interactions.
• Evaluate the effects of heat, light, oxygen, time, container closure, and storage conditions.
• Prepare stability protocols, testing schedules, reports, trend summaries, and scientifically supportable shelf-life recommendations. 7. Laboratory Quality Systems and Data Integrity
• Write and maintain laboratory SOPs, specifications, controlled test methods, forms, logs, protocols, and training materials.
• Manage instrument qualification, calibration, preventive maintenance, performance verification, service records, and change control.
• Administer chromatography software access, audit trails, data backups, data review, electronic records, and laboratory data-integrity controls.
• Manage certified reference materials, primary and secondary standards, purity corrections, storage, expiration, retest dating, and standard-solution stability.
• Maintain column inventories, solvent controls, balance and pipette calibration, temperature monitoring, water-quality records, and reagent controls. 8. Investigations, CAPA, and Trending
• Lead or support out-of-specification, out-of-trend, atypical-result, laboratory-error, and deviation investigations.
• Differentiate true manufacturing failures from sampling, extraction, instrument, standard, calculation, integration, or analyst errors.
• Perform root-cause analysis and help develop effective corrective and preventive actions.
• Trend potency, alkaloid ratios, kavalactone recovery, microbial results, supplier performance, batch yields, laboratory deviations, instrument performance, stability data, and customer complaints. 9. Third-Party Laboratory and Regulatory Support
• Serve as the technical contact for outside laboratories performing confirmatory or specialized testing.
• Review third-party methods, raw data, chromatograms, calculations, quality controls, and complete data packages rather than relying only on summary COAs.
• Coordinate split-sample comparisons, method transfer, proficiency studies, and investigations of conflicting laboratory results.
• Support GMP audits, customer audits, regulatory inspections, NDIN documentation, product substantiation files, scientific reports, and responses to technical questions. 10. Team Leadership and Training
• Train and qualify QC analysts, laboratory technicians, sampling personnel, QA reviewers, production personnel, and other employees as appropriate.
• Create analyst-qualification programs so laboratory capability does not depend on a single individual.
• Help build a scalable internal laboratory structure, staffing plan, and testing strategy. Required Qualifications
• Bachelor's degree in analytical chemistry, chemistry, pharmaceutical science, biochemistry, microbiology, food science, or a closely related scientific field.
• At least five years of hands-on analytical laboratory experience, including substantial HPLC operation and troubleshooting.
• Demonstrated experience preparing standards, calibration curves, samples, mobile phases, and quantitative analytical calculations.
• Experience with method development, method validation, method qualification, or analytical method transfer.
• Experience investigating OOS, OOT, atypical, or invalid laboratory results.
• Working knowledge of GMP documentation, controlled records, laboratory data integrity, and traceable calculations.
• Ability to independently review chromatograms and recognize interference, integration errors, carryover, poor peak shape, retention-time shifts, and system-performance problems.
• Ability to write clear SOPs, analytical methods, validation protocols, investigation reports, and technical summaries.
• Experience with microbiological testing, aseptic technique, media preparation, plating, incubation, colony counting, environmental monitoring, or microbiology method suitability. Preferred Qualifications
• Master's degree or advanced training in analytical chemistry, pharmaceutical science, natural-products chemistry, microbiology, or a related discipline.
• Experience with botanical ingredients, dietary supplements, natural products, food, pharmaceuticals, or nutraceutical manufacturing.
• Direct experience with kratom alkaloids, kava kavalactones, plant extracts, or complex botanical matrices.
• Experience with LC-MS/MS, GC-MS, headspace GC, ICP-MS, FTIR, UV-Vis, Karl Fischer, water activity, dissolution, refractometry, viscosity, density, or pH testing.
• Experience with Empower, OpenLab, ChemStation, LabSolutions, Chromeleon, or comparable chromatography software.
• Experience working under 21 CFR Part 111, 21 CFR Part 117, ISO/IEC 17025, USP, AOAC, FDA BAM, or comparable quality frameworks.
• Experience establishing an internal microbiology laboratory or environmental-monitoring program.
• Experience managing analysts, laboratory technicians, budgets, vendors, service contracts, and laboratory projects. Core Competencies
• Scientific judgment and analytical problem solving
• Chromatography troubleshooting
• Microbiological laboratory discipline
• Attention to detail and data integrity
• Clear technical writing
• Strong organization and documentation
• Cross-functional communication
• Ability to work independently in a fast-growing manufacturing environment
• Commitment to consumer safety, product quality, and scientifically defensible decision-making Physical and Work Requirements
• Full-time, on-site work in the Kansas City metropolitan area.
• Ability to work safely around laboratory chemicals, botanical materials, solvents, microbiological media, cultures, instruments, compressed gases, and heated equipment.
• Ability to wear required personal protective equipment and follow chemical hygiene, biosafety, waste-disposal, and emergency procedures.
• Ability to stand or sit for extended periods and perform repetitive pipetting, sample preparation, and instrument work.
• Ability to lift and move routine laboratory supplies and sample containers, with reasonable accommodation where applicable.

Compensation Guidance Recommended Indeed posting range: $85,000-$110,000 per year, depending on education, depth of HPLC experience, method-development capability, microbiology experience, leadership background, and familiarity with botanical or regulated-product laboratories.

Typical hiring target:

Approximately $95,000-$105,000 for a strong independent chemist who can run the laboratory, build methods, conduct microbiology testing, and support QA/QC investigations without requiring extensive day-to-day supervision. Suggested Indeed Summary MitWellness is hiring a Senior Analytical Chemist / QC Laboratory Manager to lead in-house HPLC testing of botanical alkaloids and kavalactones and to establish routine microbiological testing. The ideal candidate will have strong hands-on HPLC experience, method-development and validation capability, microbiology experience, GMP documentation skills, and the ability to support raw-material qualification, in-process testing, finished-product release, stability, investigations, and manufacturing optimization. This is a full-time, on-site position in the Kansas City metropolitan area with a base salary of $85,000-$110,000, depending on experience. Equal Opportunity Statement MitWellness is an equal opportunity employer. Employment decisions are based on qualifications, merit, business needs, and applicable law. Reasonable accommodations will be considered for qualified individuals with disabilities. Application Instructions Applicants should submit a resume and a brief description of their hands-on HPLC experience, analytical method-development work, microbiology experience, chromatography software experience, and familiarity with botanical, dietary-supplement, food, or pharmaceutical testing.

Job Type:

Full-time Pay:

$85,000.00 - $110,000.00 per year

Benefits:

401(k) Dental insurance Employee discount Health insurance Life insurance Paid time off Retirement plan Vision insurance

Work Location:

In person