Scientist I, Analytical Research and Development

Work Schedule

Environmental Conditions

Job Description

The Scientist I conducts laboratory work to assure that products are tested per operating procedures. Ensure that work is carried out in an efficient and safe manner. Applies judgment in making adaptation and modifications on all assignments. Provides routine analyses in an analytical chemistry laboratory following standard practices. Performs analytical methods as assigned for testing on raw materials, samples, stability, production intermediates, and APIs, including method development and qualification activities. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results

Key Responsibilities:

• Consistently aligns with housekeeping standards.
• Maintains a clean and safe work environment including work area, instrumentation, and testing materials.
• Understands and works in compliance with all cGMP, OSHA, and safety regulations, and SOPs.
• Performs cGMP procedures, lab procedures, BOPs and SOPs.
• Performs daily instrument calibrations / verifications as the need arises.
• Responsible for weekly/monthly inspection of safety equipment.
• Assembles and operates laboratory (bench scale) equipment and carries out experiments under guidance of a scientist.
• Conducts routine chemical testing and method development/qualification for pharmaceutical raw materials, in-process samples, and active pharmaceutical ingredient samples by internally developed and compendial test methods.
• Performs developmental and validated test methods using HPLC, GC, spectroscopy, GC/MS, LC/MS, and/or traditional wet chemical testing.
• Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems. 
• Clearly and accurately communicates the results of work by crafting 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.
• Gives information to writing of Analytical Methods, validation protocols, validation reports, and SOPs if needed.
• Solves problems related to the processing of chemical procedures.
• Ability to drive functional, technical and operational excellence.  Ability to inspire and drive team effectiveness.  Good knowledge of medical terminology, clinical data, and Good Manufacturing Practices (GMP).   Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint.  Effective written, interpersonal, and presentation skills.  Ability to work on multiple projects simultaneously.

Qualifications:

• Bachelor’s degree in chemistry or related field required.
• 1-2 years of experience working in a laboratory preferred, (GLP or GMP/cGMP environment preferred)
• 1-2 years of experience working with analytical instrumentation, such as HPLC, GC, CE, ICP and dissolution apparatus preferred
• Equivalent combinations of education, training, and meaningful work experience may be considered.
• New Graduates are considered.

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 pound 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