Scientist I

Work Schedule

Environmental Conditions

Job Description

Summary:

Provides moderately complex analyses in a chemistry or microbiological environment within defined procedures and practices. Performs analytical methods for moderately complex testing on raw materials, samples, stability, production intermediates, environmental monitoring, sterility tests, growth promotion, microbial limits tests, and or and antimicrobial effectiveness tests. Supports internal development and or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results; recommends solutions.

Essential Functions:

I. Conducts moderately complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and completed test methods.

Completes validated test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution using HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis techniques. Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems; recommends solutions. Maintains and troubleshoots analytical instrumentation as needed. 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. May interact with clients. Prepares and assists in filing regulatory documents in support of internal projects. Provides communications with outside departments, corporate sites, agencies, and clients. Writes SOPs and other instructional documents. 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 vital compliance status required by company and facility standards.

Education:

Bachelor's degree in physical science, preferably in Chemistry or Biology.

Experience:

Preferably 2 5 years of experience performing tests or analyses for pharmaceutical raw materials, finished products, or microbiological samples. Experience with common office software and chromatographic data acquisition systems preferred.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Good knowledge and understanding of chemistry and analytical instrumental technologies. Good knowledge of qualitative and quantitative chemical or microbiological analysis. Good knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry. Good problem solving skills and logical approach to solving scientific problems. Proficiency with HPLC, GC, LC MS and Dissolution techniques. Good interpersonal and communication skills (both oral and written). Good presentation skills to present information to customers, clients, and other employees. Ability to read, analyze, and interpret technical procedures and governmental regulations.