Research Associate Scientific II

Description:
Summary:
This position is responsible for analytical testing, validation/verification, and/or transfer of test method
supporting Pharmaceuticals parenteral products. Work will primarily support new product development and 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

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.
Use sophisticated laboratory instrumentation and computer systems to collect and record data (LCMS system).
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.
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 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.

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
Analytical chemistry instrumentation experience (e.g. HPLC, UPLC, UHPLC, Mass Spectrometry)
Pharmaceutical GMP laboratory experience is desired
Residue analysis experience by LC-MS/MS is desired