Lupin Pharmaceuticals
Job Overview
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 U.S. 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 fifteen 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 proud of 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 Review all analytical reports and raw and electronic data from the PD team, including raw materials, finished products, stability study samples, packaging materials, in‑process materials, cleaning analysis, and equipment calibration. Inform the PD Manager and QA when tests are not within specified limits to take appropriate actions.
Essential Duties and Responsibilities
Ensure that analytical data generated meets company standards and regulatory requirements.
Perform review of all test results, raw data, and electronic data generated in support of testing of raw materials, in‑process, finished product and stability samples including assays, chromatographic purity, content uniformity using HPLC/UPLC, particle size distribution using different techniques (e.g., Malvern), density, water determination by KF, and tests according to the in‑house monographs and USP in a regulated laboratory environment.
Check all laboratory notebooks and associated documents for correctness of raw data and verify that all reagents, standards, and equipment used are within the acceptance range.
Review raw data for its audit trails and instrument logs on cGMP instrumentation and equipment for laboratory data release.
Review all validation and method optimization reports.
Ensure chemists follow all SOPs and cGMP regulations and use the correct method or procedure for each product.
Ensure notebooks are reviewed in a timely manner, in accordance with SOPs. Sign off on all analytical test results and reports.
Analyze and interpret results in written and oral format.
Work with analysts for document corrections and provide guidance accordingly. Guide analysts on laboratory notebook documentation requirements.
Follow all SOPs and safety guidelines to ensure compliance with a cGMP environment and safety practices.
Provide the required support during the regulatory and internal audits.
Perform additional tasks as assigned by the QA supervisor.
Qualifications
Bachelor’s degree in Chemistry or a related field.
5+ years of related experience in pharmaceutical analysis and QA data review.
Previous experience using all types of analytical instrumentation, software, and tests performed in the lab, including HPLC/UPLC, GC, FT‑IR, and Empower.
Understanding of SOPs, ICH, USP/NF procedures, and requirements.
Previous cGMP/regulatory experience is preferred.
Equal Opportunity Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
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 up to 15 pounds occasionally. Generally work is performed in an office environment.
Search Firm Representatives Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails.
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Responsibilities Review all analytical reports and raw and electronic data from the PD team, including raw materials, finished products, stability study samples, packaging materials, in‑process materials, cleaning analysis, and equipment calibration. Inform the PD Manager and QA when tests are not within specified limits to take appropriate actions.
Essential Duties and Responsibilities
Ensure that analytical data generated meets company standards and regulatory requirements.
Perform review of all test results, raw data, and electronic data generated in support of testing of raw materials, in‑process, finished product and stability samples including assays, chromatographic purity, content uniformity using HPLC/UPLC, particle size distribution using different techniques (e.g., Malvern), density, water determination by KF, and tests according to the in‑house monographs and USP in a regulated laboratory environment.
Check all laboratory notebooks and associated documents for correctness of raw data and verify that all reagents, standards, and equipment used are within the acceptance range.
Review raw data for its audit trails and instrument logs on cGMP instrumentation and equipment for laboratory data release.
Review all validation and method optimization reports.
Ensure chemists follow all SOPs and cGMP regulations and use the correct method or procedure for each product.
Ensure notebooks are reviewed in a timely manner, in accordance with SOPs. Sign off on all analytical test results and reports.
Analyze and interpret results in written and oral format.
Work with analysts for document corrections and provide guidance accordingly. Guide analysts on laboratory notebook documentation requirements.
Follow all SOPs and safety guidelines to ensure compliance with a cGMP environment and safety practices.
Provide the required support during the regulatory and internal audits.
Perform additional tasks as assigned by the QA supervisor.
Qualifications
Bachelor’s degree in Chemistry or a related field.
5+ years of related experience in pharmaceutical analysis and QA data review.
Previous experience using all types of analytical instrumentation, software, and tests performed in the lab, including HPLC/UPLC, GC, FT‑IR, and Empower.
Understanding of SOPs, ICH, USP/NF procedures, and requirements.
Previous cGMP/regulatory experience is preferred.
Equal Opportunity Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
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 up to 15 pounds occasionally. Generally work is performed in an office environment.
Search Firm Representatives Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails.
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