Scientist III, AR & D at Amneal Pharmaceuticals LLC (J0P) in Piscataway, New Jersey

Job Description:

Description:

The Scientist 3 of Analytical R&D group conducts qualitative and quantitative chemical analyses or experiments in laboratories to quality and to develop new products for the pharmaceutical dosage forms. This individual performs all analytical method development, qualifications and method validations for active pharmaceutical ingredients, excipients and the finished product pharmaceutical dosage forms. More over this individual performs testing of in-process and release activities to support the formulation development. This individual analyzes organic or inorganic compounds using chromatography, spectroscopy or spectrophotometry techniques and conduct quality control tests. This individual maintains laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed. The Scientist-3 assists Group Leader/Manager with training other scientists for analytical instrument/equipment. Additionally, this individual drives advances in analytical capabilities for all analytical techniques using scientific rules and methods to solve analytical problems.

Essential Functions:

• Develops and optimizes new and existing analytical methods for qualification and release testing of the products. Develops stability indicating product testing methods and performs method validation, complying with all applicable regulations, guidelines and internal SOPs.

• Expands analytical capabilities of the department. Provides training and guidance to Analytical Group members with developing technical skills.

• Provides timely responses to internal and external inquiries related to pharmaceutical testing and quality.

• Prepares scientific or technical reports or presentations for analytical development and analysis.

Additional Responsibilities:

• Additional responsibilities includes staying abreast of new development in analytical techniques such as High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Fourier Transform Infrared Spectroscopy (FT-IR), Ultraviolet-visible (UV-Vis) spectrometers, Karl-Fischer titrator (KF titrator) and Dissolution apparatus. Contributes to improvement in laboratory operations to increase efficiency.

Education:

• Bachelors Degree (BA/BS):  Chemistry or related science - Required

• Master Degree (MS/MA):  Chemistry or related science - Preferred

Experience:

• 5 years or more experience in pharmaceutical (with Bachelor's Degree) is required.

• 3 years or more experience in pharmaceutical (Master's Degree) is preferred.

Skills:

• Enthusiasm and dedication performing as an individual contributor and in a team environment. - Intermediate

• Written and verbal communication and presentation skills. - Intermediate

• Ability to set priorities and to follow through on commitments utilizing organizational skills. - Intermediate

• Microsoft Office and ability to learn additional software/programs as needed. - Intermediate

• Ability to lead projects, and meet deadlines. - Intermediate

• Creativity to solve technical and compliance problems. - Intermediate

Specialized Knowledge:

• Knowledge of modern analytical instrument/equipment and techniques. Experience with High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), UV-Visible Spectrophotometer (UV-Spectrophotometer), Fourier Transform Infrared Spectroscopy (FT-IR), Dissolution apparatus and general laboratory equipment/instrument. Method development and validation knowledge or experience.