MD Analytical Scientist I - 1st Shift

SUMMARY

Provides scientific and analytical support contributing to cGMP lab work in the development of new analytical methods and improvements of existing methods by performing the following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Develops scientifically valid testing methods (i.e. identity, purity, strength, and composition as well as limits on contaminants, adulterants) for both incoming raw materials and products to meet the qualitative and quantitative claims for active ingredients/strength markers.
• Writes standard operating procedures, justifications, investigations and testing methods in compliance with company policies and procedures and cGMPs.
• Performs required lab work and/or reference searches in analytical chemistry, chemistry and biochemistry to facilitate NOW product analyses and development.
• Provides training and mentoring to QC analytical laboratory staff.
• Executes method transfers to QC lab on-site and at satellite locations.
• Verifies, adopts and applies official analytical methods (i.e. AOAC, USP) and other published methods to raw materials and finished products.
• Troubleshoots and solves technical problems that occur during innovative analytical methods development and regular QC testing.
• Develops procedures for separating and isolating active components, and/or strength markers to be used in innovative analytical methods to be used as reference standards.
• Obtains information about natural products and methods of their analytical determination procedures from sources such as scientific literature, conferences, seminars, and the Internet.
• Develops procedures for potential savings and increased efficiency in new and current testing methodologies.
• Complies with safety and GMP requirements.

SAFETY RESPONSIBILITY STATEMENT

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 to learn what constitutes a safety hazard, reporting safety concerns to management or safety teams, submitting safety suggestions, and correcting or reporting to the appropriate people when the employee sees a workplace health or safety hazard until it is resolved. Assists with communicating safety information to new employees. Fulfills responsibilities as outlined in the company safety management plan.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below represent the knowledge, skill, and/or ability required.

EDUCATION and/or EXPERIENCE

• Bachelor’s degree (B.S.) or equivalent from a four-year College or technical school in a laboratory science field (i.e. chemistry, biology, biochemistry, or nutritional science).
• A minimum of three years industry laboratory experience, including a minimum of one year method development.
• Familiarity with general laboratory safety, procedures, instrumentation, and laboratory equipment experience, including hands-on instrumental analysis (such as analytical balance, pH meter, FTIR, NIR, HPLC, LC-MS, HPTLC, GC, GC-MS, ICP-MS, ICP-OES or UV-Vis) is required
• Excellent computer skills required, including Microsoft Word and Excel.
• Experience with database management systems such as Oracle, LIMS and Epicor are desired.
• Knowledge of cGMP regulations.
• A combination of education and experience that meets these criteria will be considered.

LANGUAGE SKILLS

Ability to read and interpret product specifications, departmental instructions, and procedure manuals. Ability to read, analyze, and interpret chemical and biomedical periodicals, professional journals, technical procedures, and procedure manuals. Ability to communicate effectively verbally and in writing. Ability to effectively present information and discuss issues with groups of managers, scientists and coworkers.

MATHEMATICAL SKILLS

Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, averages, ratios, proportions, and the metric system to practical situations.

REASONING ABILITY

Excellent problem-solving skills. Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

OTHER SKILLS AND ABILITIES

Familiarity with nutraceutical and herbal products and their application is desirable.

Knowledge of chemical laboratory instrumentation. Excellent time management, meeting deadlines, attention to detail, verbal and written communication skills, listening, decision-making, troubleshooting/problem-solving, and organization skills required. Must possess strong organizational skills, be a self-starter, and be able to handle multiple tasks. Must possess a professional attitude and work well with peers and management. Ability to work as an individual contributor as well as part of a cross functional team. Ability to lead cross functional teams in short and long term projects.

PHYSICAL DEMANDS

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

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee must frequently stand, walk, and reach with hands and arms. The employee is required to regularly use a telephone, a computer, and analytical instrumentation and devices. The employee is occasionally required to taste or smell. The employee must frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, and the ability to adjust focus. Performing repetitive activities, such as using a pipette or vial crimper are required.

WORK ENVIRONMENT

The work environment characteristics described here represent those encountered by an employee while performing the essential functions of this job.

The employee is frequently exposed to vapors and/or herbal aromas. The noise level in the work environment is usually moderate. The employee may be exposed to potentially hazardous chemicals and biological materials. Safety training and personal protective equipment are available and required.