Lead / Manager – Analytical Development & QC Laboratory

Experience Level: 6–10 Years (Pharmaceutical / High-End Cosmeceutical / Botanical Analysis)

Education: M.Pharm (Pharmaceutical Analysis) / M.Sc. or Ph.D. in Analytical Chemistry

About the Role

We are seeking an experienced, rigorous Analytical Method Development & QC Lead to design, establish, and operate our in-house testing laboratory from the ground up.

In this role, you will serve as the technical gatekeeper for raw material integrity and formulation stability across our personal care product company and clinic network. You will be directly responsible for qualifying and verifying incoming raw materials (high-purity lipids, surfactants, solvents, and botanical extracts), developing and validating custom HPLC/UHPLC analytical methods, and resolving active marker compounds in complex matrices.

If you are an expert chromatographer who knows how to build robust methods, troubleshoot high-pressure instrumentation, and detect raw material adulteration or degradation before it enters production, this role is built for you.

Key Responsibilities

1. Lab Setup, Instrument Qualification & Operations

Lead the procurement, installation, calibration, and IQ/OQ/PQ qualification of analytical instrumentation, including HPLC/UHPLC systems (PDA/UV), Karl Fischer titrators, rotational viscometers, density meters, and analytical balances.

Design laboratory standard operating procedures (SOPs), chemical inventory logs, column maintenance schedules, and safety protocols.

Maintain chromatographic columns and hardware consumables (preventive maintenance, frit protection, line purging, and pressure diagnostics).

2. Raw Material Inbound Verification & "Quarantine & Release" Gatekeeping

Establish rigorous "Quarantine and Release" specifications for all incoming active ingredients, functional excipients, and solvents (e.g., HSPC, CoQ10, DEGEE, Cetyl Alcohol, organic acids).

Perform routine chemical assays: chromatographic purity, water content (Karl Fischer), acid/peroxide values, and specific gravity.

Audit vendor Certificates of Analysis (COAs) against independent empirical bench testing to identify counterfeit, cut, or degraded raw material batches.

3. Method Development & Marker Assay (Botanicals & Actives)

Develop, optimize, and validate robust reversed-phase HPLC/UHPLC gradient methods from scratch according to ICH Q2 guidelines (Specificity, Linearity, Accuracy, Precision, LOD/LOQ).

Establish extraction cleanup protocols (liquid-liquid extraction, solid-phase extraction [SPE]) to isolate and quantify target bioactive markers in dirty botanical and fungal extracts without column fouling.

Utilize Photodiode Array (PDA/DAD) detectors to evaluate spectral libraries, monitor baseline drift, and verify peak purity against authentic reference standards.

4. Stability Testing & Finished Product Release

Design and execute accelerated and real-time stability testing protocols (climatic chamber monitoring, freeze-thaw cycles) for topical formulations.

Monitor active degradation pathways, assay loss, and chemical compatibility in complex cosmetic matrices (e.g., high-electrolyte W/O emulsions, anhydrous suspensions).

Required Technical Skills & Qualifications

Chromatography Expertise: Extensive hands-on mastery of HPLC and UHPLC systems (Shimadzu LabSolutions, Waters Empower, or Agilent OpenLab). Proven experience operating sub-2 µm narrow-bore columns under high-pressure regimes (>400–600 bar).

Botanical & Active Assay Development: Proven track record of developing quantitative methods for lipid-soluble actives (e.g., quinones, polyphenols, triterpenes) and separating target markers from co-eluting plant matrices.

Wet Chemistry & Compendial Testing: Proficiency in Karl Fischer titration, potentiometric acid-base titrations, UV-Vis spectrophotometry, refractive index, and specific gravity.

Troubleshooting: Deep mechanical and fluidic understanding of chromatographic systems (system dwell volume, gradient delay, inlet frit blockage, pressure surges, void volumes, peak splitting).

Preferred Experience

Prior experience setting up a new QC/R&D analytical laboratory or preparing an analytical lab for GLP/NABL/ISO 17025 audits.

Experience in synthetic or botanical marker isolation, flash chromatography, or sample preparation for LC-MS.

Work Location: In person