Job description
Overview:
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 a written and oral format. Perform data review and manage testing schedules and stability pulls.
Essential Duties and Responsibilities
Education & Experience
If you are hired, Lupin will require you to prove that you are fully vaccinated against COVID-19, unless you are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents you from becoming vaccinated. As an employee, you will be required to follow Lupin policies related to any additional or future COVID-19 vaccination or booster shot requirements.
Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.
Responsibilities:
Role
Summary
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 a written and oral format. Perform data review and manage testing schedules and stability pulls.
Essential Duties and Responsibilities
Perform routine tests of finished product and stability samples, raw materials and CV samples, including, assays, chromatographic purity, content uniformity using UV, GC and HPLC, particle size distribution using different techniques including, water determination by KF, and tests according to the in-house monographs and USP in a regulated laboratory environment.- Evaluates test results and decide the acceptability of the samples based on the test results.
- Review QC data and manage the QC team’s testing and stability pulls.
- 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 compliance with cGMP.
- Ensure notebooks are reviewed promptly, in accordance with SOPs.
- Analyze and interpret results in written and oral format.
- Training of new analysts.
- Monitor the team’s training compliance in the company procedures.
- Notify management promptly of any laboratory-related or other discrepancies.
- Conduct Laboratory investigations and initiate Quality Events, CAPA and Change Controls as needed
- Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment
Education & Experience
- Bachelor’s degree in Chemistry or related scientific field and 3-5 years related experience in the pharmaceutical industry OR Master’s degree in Chemistry or related scientific field and 2 year related experience in the pharmaceutical industry.
- Familiarity with analytical methodology, laboratory practices, wet-chemistry, HPLC/UPLC, UV-Vis, etc., preferred.
- 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.
- Assist in the validation of Quality Control methods.
- May lead and direct the work of others.
- A wide degree of creativity and latitude is expected.
- Knowledge of Excel and MS-office, Powerpint
- Excellent communication skills, including the ability to speak, listen and gain clarification, respond well to questions, and write clearly and informatively.
P
hysical 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.
Qualifications:
COVID19 Vaccination Requirements:
If you are hired, Lupin will require you to prove that you are fully vaccinated against COVID-19, unless you are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents you from becoming vaccinated. As an employee, you will be required to follow Lupin policies related to any additional or future COVID-19 vaccination or booster shot requirements.
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