Contract Quality Control Chemist

Overview

Lupin U.S. is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions.  Somerset, New Jersey is home to one of eighteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin. Somerset, New Jersey is also the location for Lupin's U.S. Sales Operations and Marketing divisions, as well as internal Product Development teams. Lupin has a significant generic pipeline and a growing Specialty Brand presence in the U.S.  Our Inhalation Research and Development facility is located in Coral Springs, Florida focusing on generic and branded orally inhaled and nasal drug products.  Key shared service functions are found at our beautiful harbor side location in Baltimore, Maryland.  Adding to Lupin's U.S. footprint is a robust team of Clinical Operations experts in Blue Bell, Pennsylvania and a high performing Specialty salesforce located across the country.  Lupin is prided on being people-focused and centered around how impactful we are with our customers.  Join our U.S. team and become part of an organization that encourages professional development and innovation!  We are looking for passionate and driven individuals who will help us to continue making medicine widely accessible to patients, and who strive to work by Lupin's Core Values of Teamwork, Passion for Excellence, Entrepreneurial Spirit, Respect and Care, Integrity, and Customer Focus.

Responsibilities

Role Summary

 

The Contract Chemist will perform testing and decide on the acceptability of the in-process, process validation samples, finished products, stability samples, raw materials, CV samples and developmental samples in a regulated laboratory environment. Analyze and interpret results in written and oral format. 

 

This is a monday - friday work schedule contracted through a third pary agency. 

 

Essential Duties and Responsibilities

 

• Perform routine tests of finished product and stability samples, raw materials and CV samples, including dissolution, assays, chromatographic purity, content uniformity using UV and HPLC, particle size distribution using different techniques including Light Scattering (e.g. Malvern), density, water determination by KF, and tests according to the in-house monographs and USP in a regulated laboratory environment.
• Evaluates test results and decides the acceptability of the samples based on the test results.
• Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
• Maintain the laboratories with good housekeeping practices and in compliant with cGMP.
• Ensure notebooks are reviewed promptly, in accordance with SOPs.
• Design and develop test methods, perform experimental tests, and evaluate performances.
• Write test methods, method validation protocols and reports.
• Establish test specifications and communicate with internal and external customers.
• Analyze and interpret results in written and oral format.
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment

Qualifications

Education& Experience

• Bachelor's degree in Chemistry or related scientific field and 1 - 2 years related experience in pharmaceutical analysis OR Master's degree in Chemistry or related scientific field and 1+ year related experience in pharmaceutical analysis.
• To perform this job successfully, an individual should have:
• Ability to deal with problems involving several concrete variables in standardized situations.
• Ability to carry out necessary computations and to draw and interpret graphs.
• Working knowledge of instrumentation software used in the laboratories.
• Aid in the writing of laboratory practices and procedures.
• Helps assist in the generation of laboratory practices and modifications of standard operating procedures.

Physical Requirements

 

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking, and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting to 15 pounds occasionally. Generally work is performed in a laboratory environment.

Employment Type: OTHER