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Form of workJob 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
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
