This position will conduct chemical development and bench work on a range of substances and company products. This position will also assist R&D with formulation platform development, raw material analysis, training/development of pilot batches in Manufacturing, optimizing batching processes for repeatability, and creating and issuing specifications to Quality Control.
• Develops formulas, batch processes, and laboratory/production instructions; creates all batch record components, and any other GMP-required documentation.
• Develops analytical test methods for bulk product, raw materials, and finished products and any other GMP-required responsibilities.
• Runs all lab pilot batches then assists with first batch production runs, then trains manufacturing personnel on batch records.
• Assists manufacturing with batch adjustments, troubleshooting problem products/processes, and is a technical resource.
• Performs design of experiments and qualifications on formulations and batch processes to assure each formula is optimized for consistent results in manufacturing.
• Manages stability testing and creates records of the results including freeze/thaw and accelerated shelf life testing.
• Keeps a clean and safe lab environment.
• Performs other duties as assigned.
• Bachelor’s degree in science or closely related field is required.
• Minimum of 2 years in a process-based environment, specifically, chemical batch processing in an FDA regulated industry.
• Minimum of 2 years basic analytical method development.
• Minimum of 3 years of experience in a practical hands-on lab environment (may include academic lab settings).
• Knowledge of organic and analytical chemistry to include solutions, dispersions, suspensions and emulsions is preferred, testing methods of formulated products but not required.
• Ability to competently prioritize and handle multiple tasks.
• Ability to work with little supervision and use independent discretion.
• Ability to operate computerized lab equipment and maintain accurate data/records.
• Good oral and written communication skills.
• Strong analytical and problem solving abilities.
• Detail oriented with excellent organizational skills.
• Team oriented and able to successfully work independently or in a collaborative/group setting.
• Flexible, adaptable, and capable of working in a fast paced environment.
“PHYSICAL DEMANDS & WORK ENVIRONMENT”
The physical, mental, and environmental conditions in which the work is performed. The demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to sit, stand, walk and use hands and fingers to operate a computer keyboard, mouse, and telephone to talk and hear. The employee is frequently required to sit and reach with hands and arms. The employee is occasionally required to lift up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
• The noise level in the work environment is usually moderate.
• This position may require evening and weekend work depending on business needs.
NOTICE: The above statements are intended to describe the general nature of the environment and level of work being performed by this job. This job overview in no way states or implies that the duties and responsibilities listed are the only tasks to be performed by the associate in this job. The associate will be required to follow any other instructions and to perform any other job related duties requested by his or her supervisor.
This job description supersedes prior job descriptions. When duties and responsibilities change and develop, the job description will be reviewed and is subject to changes of business necessity.