Research Associate Scientific II.
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Department/Function: Pharmaceuticals R&D Sustaining Product Organization/Stability
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, physical, and biological 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 biological and 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
- 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 2-5 years of experience or advanced degree in Chemistry or Biological Sciences
- Analytical chemistry instrumentation experience (e.g. HPLC, UPLC, UHPLC, GC, pH, KF, TOC, AA, GFAA, titration, etc.)
- Pharmaceutical GMP laboratory experience is desired
- Stability study execution and validation experience is desired