Research Associate Scientific II - Integrated Resources, Inc

Research Associate Scientific II
Fieldglass description:

Department/Function: Pharmaceuticals R&D/Stability Lab

Summary:
This position is responsible for analytical testing, validation/verification, and/or transfer of test method supporting Pharmaceuticals parenteral products. Work will primarily support stability testing, but may also support new product development and/or sustaining product initiatives.
The individual in this position must:
" Effectively contribute solid technical knowledge to a variety of projects within the relevant discipline with minimal assistance.
" Display basic technical understanding of related disciplines.
" Conduct routine/non-routine research and design experiments with minimal assistance

The individual must not be allergic to Penicillin, Cephalosporin, or their related products and/or materials.

Essential Duties and Responsibilities:
" Conduct critical chemical and physical analyses on finished product stability samples. May also support testing of raw materials, initial, in-process, and final product samples from manufacturing facilities or department projects. Work under minimum supervision.
" Perform review of test data, which includes overall documentation practices. Perform review functions in LIMS or other computerized systems.
" Use sophisticated laboratory instrumentation and computer systems to collect and record data. May be required to be a system owner or conduct validations.
" Perform advanced chemical assays requiring precise analytical skills and understanding of chemistry principles. Complete all testing, including special project / protocol testing in a timely and appropriate manner to meet project schedules
" Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, cGxP, and QSR regulations.
" Investigate deviations and write exception documents.
" Collaborate with other functions/departments to solve problems, increase efficiency, improve quality and provide product support.
" Maintain laboratory safety requirements, perform equipment maintenance/calibration, and troubleshoot basic instrument problems

Qualifications:
" Must have good oral and written communication skills, strong analytical skills and be detail oriented.
" Proficient in advanced wet chemistry, volumetric preparation techniques and instrumental methods of analysis
" Must demonstrate effectiveness in ability to train others, leadership, organization, teamwork/interpersonal skills, results orientation, and task completion
" Must be able to handle multiple tasks concurrently and in a timely fashion
" Possess writing and computer skills
" Must communicate effectively with managers, peers, and subordinates.
" Interpret available information and make recommendation to resolve technical challenges

Physical Activities and Requirements:
" Must be able to hand write and use computers for the majority of the work day
" Must be able to transfer materials, mix solutions/product(s), open products, and perform laboratory testing
" May require standing for extended periods
" Must be able to lift up to 10 pounds routinely
" This work is subject to hazards including exposure to chemicals, drug products, and bacteria. This includes Penicillin, Cephalosporin, their related products and/or materials

Education and/or Experience:
" Bachelors degree in relevant scientific discipline (e.g. chemistry, pharmaceutical sciences) with analytical chemistry laboratory coursework and at least 2 years of experience
" Analytical chemistry instrumentation experience (e.g. HPLC, UPLC, UHPLC, pH, KF, titration, etc.)
" Must have HPLC experience; Empower experience is preferred.
" Electronic Lab Notebook experience is desired.
" Pharmaceutical GMP laboratory experience is desired.
" Stability study execution and validation experience is desired.