Research And Development Chemist

Job Description

Please note: For confidentiality purposes, this position is not located in Blue Bell. The role is based in the tri-state area.

This role will focus on the validation of analytical methods for products in development or for commercial products when needed. This position involves executing validation studies and optimizing or developing analytical methods when needed to support drug product applications. In addition to analytical method validation, this position will involve R&D T0 and Stability testing for 2-3 drug products in development

Key responsibilities.

• Develops analytical methods that are accurate, precise, and specific for use in both the Quality Control department and the Research department. Methods primarily include HPLC and GC but also include ICP-MS, Karl Fisher, solid-state characterization, and others.
• Documents the development of the method in the appropriate notebooks for future reference. Performs pre-validation work ahead of transfer to the Validation Department to demonstrate suitability for use.
• Prepares test method procedures and supporting documentation for use in the Quality Control laboratory.
• May be required to develop validation protocols and validate analytical methods used in the testing of raw materials, intermediate products, final products, and cleaning samples.
• Assists in the maintenance and calibration of laboratory analytical instrumentation including, but not limited to HPLC and GC. Maintains accurate records regarding the maintenance and calibration activities.
• May support manufacturing operations with testing of raw materials, intermediate products, final products, and cleaning samples. The incumbent is expected to operate in a neat and orderly manner and to provide accurate and timely test results.
• Assists in the maintenance of the QC Laboratory. In addition to routine housekeeping and glassware cleaning, maintains and appropriate inventory of supplies and chemicals.
• Documents sample preparation, equipment set-up and test results in Laboratory Notebooks or on the appropriate test record form. Documentation must be complete and verified by a second member of the quality group. In addition, laboratory log sheets, those related to equipment usage, calibration, and maintenance, reference standard inventory, QC chemical inventory, or those related to retention samples will be properly maintained.

EDUCATION/EXPERIENCE.

• A Bachelor’s Degree in Chemistry (Master's or PhD Degree is preferred)
• A minimum of 7 years of experience in small molecule pharmaceutical laboratories, with a strong background/proficiency in LC, GC, Dissolution and chromatographic method validation and development.
• Proficient with Empower software.
• Strong organizational skills.
• Good communication skills
• Good writing skills.