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Quality Control Chemist
Lupin Pharmaceuticals Inc.
2021-12-03 11:30:03
Somerset,
New Jersey,
United States
Job type: fulltime
Job industry: Science & Technology
Job description
Overview:
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
Physical Requirements
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:The Quality Control Chemist for the drug product testing reports to the Finished Product/Stability Supervisor. The primary purpose of the job is to perform testing and make calculated decisions on the acceptability of process validation samples, raw materials, finished products, stability samples, and developmental samples in a regulated laboratory environment in support of timely disposition of manufactured products.
- Perform routine stability tests using stability indicating methods including dissolution, assay, related compounds, chromatographic purity etc. Additionally, individual shall be aware of commonly used wet analysis techniques, particle size distribution, density, water determination by KF, and other tests to perform test according to the in-house specifications and methods and USP monographs using classical wet chemistry and instrumental techniques.
- Follow written operating procedures to perform routine tests like dissolution, assays, blend uniformities, related compounds, chromatographic purity, residual solvents, particle size distribution, Infra-red spectroscopy using different techniques and instrumentation like Dissolution, UV, HPLC, GC, IR etc.
- Evaluate test results and decide acceptability of the samples based on the test results. Review and release the raw data, documentation and results for certificate of analysis.
- Write draft technical documents like specifications, analytical methods, method verification protocols and reports, method transfer documents, investigation reports etc.
- Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
- Follow SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices. Maintain the laboratories with good housekeeping practices and in compliant with cGMP.
- Other duties related to departmental activities may be assigned by management based on situation and necessity
- Bachelor's Degree in Chemistry or related scientific field and 3+ years' industry experience as a Chemist or Master's Degree in Chemistry or related scientific field and 1+ years' industry experience as a Chemist
- Knowledge of current GMP guidance, applicable USFDA and ICH guidelines and regulatory requirements (such as USP/ICH requirements)
- Ability to make observations with instruments and analysis techniques
- Basic knowledge of instrument techniques and software for instruments like HPLC, GC, IR, KF, metrohm titrator, etc. Previous experience with Empower is plus.
- Ability to carry out necessary computations and to draw and interpret graphs.
- Basic knowledge of method validation, method transfer and method verification of the analytical methods is plus.
- Knowledge of basic to advance level of computer skills.
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
Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Work is performed in an office environment.