Research Associate Scientific

Responsibilities :

• 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.
• 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.
• 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. 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 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.

Requirements :

• 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.
• Must be able to hand write and use computers for the majority of the workday.
• 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 to 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.
• Bachelor's degree in relevant scientific discipline ( chemistry, pharmaceutical sciences) with analytical chemistry laboratory coursework and at least years of experience.
• Analytical chemistry instrumentation experience ( HPLC, UPLC, UHPLC, pH, KF, titration, etc).
• Must have HPLC experience; Empower experience is preferred.
• Electronic Lab Notebook experience is desired.
• Pharmaceutical GMP laboratory experience is desired.
• Stability study execution and validation experience is desired.
30+ days ago