Associate Scientist I – R&D

Job Description

Job Summary:

• Provides routine analyses in a chemistry or microbiology environment by following standard practices.
• Performs analytical methods as assigned for testing on raw materials, samples, stability, environmental, production intermediates, and/or human cells.
• Supports internal development and/or manufacturing operations.
• Makes detailed observations and reviews, documents, and communicates test results.

Duties and Responsibilities:

• Conducts routine chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods.
• Executes validated test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and/or traditional wet chemical testing.
• Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems.
• Performs daily instrument calibrations / verifications as required.
• Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results.
• Records and reports results of analysis in accordance with prescribed lab procedures and systems.
• Assists in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.
• Contributes to writing of SOPs if needed.
• Cleans and organizes work area, instrumentation, and testing materials.
• Cleans HPLC and dissolution systems after use.
• Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing
• Practices, Good Laboratory Practices, and Safety guidelines.
• Maintains the necessary compliance status required by company and facility standards.

Required Knowledge, Skills, and Abilities:

• Bachelor’s degree in physical science, preferably in Chemistry or Biology.
• Good knowledge and understanding of basic instrumental technologies.
• Knowledge of qualitative and quantitative chemical or microbiological analysis.
• Awareness of quality and regulatory requirements in the pharmaceutical industry.
• Good problem-solving skills and logical approach to solving scientific problems.
• Demonstrable interpersonal and communication skills (both oral and written).
• Ability to read and interpret technical procedures and governmental regulations.
• Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques.

Work Environment & Physical Requirements:

• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
• Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.