Round Lake - IL Contract 2 months ago
Stefanini Groupis hiring for a
Research Associate Scientific II.

Exciting opportunity awaits! Let us help you get started. Call Aditya Yadav – 248-728-6487or email me on

Aditya.Yadav@stefanini.com

Department/Function: Pharmaceuticals R&D Sustaining Product Organization/Stability

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, 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
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 2-5 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
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