USA - Research Associate Scientific II

Description:

Department/Function: Pharmaceuticals R&D/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/nonroutine 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 inprocess 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 25 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