SUMMARY

This Analytical Chemist position holder will be responsible for conducting a variety of tasks, including performing Method Development and Validation for new products, testing raw materials, in process, and finished products, maintaining proper documentation. All tasks will be performed according to the Company’s Standard Operating Procedures (SOPs) and generally accepted industry practices including USP (United States Pharmacopeia), NF (National Formulary), FCC (Federal Chemistry Code) and AOAC (Association of Official Analytical Chemists) testing monographs.

Responsibilities

• Interacts with other departments to communicate necessary information.
• To ensure that all analysis is accurate and follows standardized laboratory procedures.
• To ensure laboratory standards are properly prepared and laboratory notebooks are up to date.
• Coordinate all special projects in the HPLC laboratory.
• Write Standard Operating Procedures for HPLC regarding all in-process and finished products.
• Maintains a laboratory following cGMP Practices.
• Manage multiple projects simultaneously and collaborate with other departments to solve non-routine problems.
• Improve the current operations through suggestions on how improvements can be made to the current process and generate data to support the improvements.
• Performs method development/ validation tasks.

Qualifications To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Use discretion in handling confidential and sensitive matters
• Must be able to resolve conflict in a professional and expeditious manner
• Must be able to prioritize work and complete assignments with little to no supervision
• Must possess ability to establish and maintain effective working relationships with supervisors, personnel, co-workers, subordinates, customers and the public
• Strong knowledge of basic chemistry formulas and characteristics
• Knowledge of batch-adjustments for liquid products

Education, Experience and Licensure

• Bachelor’s degree in chemistry, or any related science
• Minimum two years’ experience of performing HPLC analysis in analytical laboratory in the pharmaceutical, nutritional supplement or cosmetics industry

Technical Skills

• Proficient use of Microsoft Office products including Word, Excel, and Outlook; and application software for advanced instrument analytics
• Must have good visual/organoleptic alertness, aseptic techniques in testing of the products
• Knowledge to operate basic analytical instrumentation, UV/VIS (Ultraviolet & Visible) spectrometer, FT-IR (Fourier Transform Infrared) spectrometer, thermometer, pH-meter, conductivity meter, TOC (Total Organic Carbon) analyzer, Densitometer, viscometer dissolution/disintegration, particles analyzer, and perform the necessary calculations
• Knowledge and ability to operate and troubleshoot advanced analytical instruments: HPLC (High Performance Liquid Chromatography); GC (Gas Chromatography), ICP-MS (Inductively Coupled Plasma- Mass Spectrometry)
• Knowledge to perform chemical ID tests and other assay according to SOP and other published monographs, which has defined in the summary.

Language Skills Must demonstrate good command of the English language, communicating clearly and concisely communicate verbally and in writing to individuals and groups.

Mathematical Skills Must have college level mathematic skills. Compute basic and advanced mathematical equations such as addition, subtraction, division, multiplication, percentages and statistics. Ability to analyze results.

Physical Demands and Work Environment The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions.

• Work will be conducted in an FDA (Food and Drug Administration) and DEA (Drug Enforcement Agency) regulated pharmaceutical laboratory environment with risk of exposure to various chemicals and bacterial organisms associated with the manufacture of pharmaceuticals, nutritional supplements and cosmetics.
• Distractions such as noise from telephones, keyboards, talking, paging systems and equipment are common.
• Temperatures are regulated by facilities management and are not within the direct control of the individual.
• Position requires the incumbent to move from the work area to other areas of the company, including other offices, cubicles, warehouse and production areas, conference rooms and other offices in the same building or another building. The incumbent may be required to walk or drive his or her own vehicle to a second location a short distance away.
• Must be able to sit and/or stand for up to eight hours per day, lift and carry up to 20 lbs. with or without assistance, reach above shoulder height, bend, stoop, and crawl to retrieve items from under a desk or floor level cabinet or drawer; push and pull, use a computer keyboard and laboratory equipment throughout the workday while performing essential responsibilities.
• Exposure to standard chemicals used in an office environment is expected and includes but is not limited to toner, glue and liquid paper or white out.
• Exposure to chemicals, bacterial organisms and materials used in the manufacturing process of nutritional supplements, cosmetics, and prescription drugs and encountered in a laboratory and manufacturing environment.