Analytical Chemist
2 weeks ago
Overview:
Lupin Pharmaceuticals Inc. is a dynamic and rapidly expanding organization that integrates manufacturing, Research and Development, and commercial sectors. These divisions collectively contribute to our generic and branded business in the U.S. Lupin boasts a substantial pipeline of generic products and a dedicated focus on women's health.
Our inaugural Research and Development facility in the United States is situated in Coral Springs, Florida, specializing in both generic and branded orally inhaled and nasal drug formulations.
Somerset, New Jersey, hosts one of our fifteen global commercial manufacturing sites, which is also the sole commercial manufacturing facility in the U.S. for Lupin, alongside additional Research and Development teams.
At Lupin, we pride ourselves on being people-centric, emphasizing the impact we have on our customers. Our success is measured not by financial metrics but by the lives we positively influence along the way.Responsibilities:
Key Duties and Responsibilities
The primary objective of this role is to conduct testing and determine the acceptability of process validation samples, raw materials, finished products, stability samples, and developmental samples within a regulated laboratory setting, ensuring timely product disposition.
Conduct routine release testing of raw materials and finished products, including wet chemistry analysis, dissolution, content uniformity, assay, particle size distribution, density, and water determination by Karl Fischer, along with other tests in accordance with in-house specifications and methods and USP monographs, utilizing classical wet chemistry and instrumental techniques.
Perform routine assays, related compound testing, chromatographic purity assessments, residual solvent evaluations, and particle size distribution analyses, employing various techniques and instruments such as UV, HPLC, GC, and IR.
Draft technical documents, including specifications, analytical methods, method verification protocols and reports, method transfer documents, and investigation reports.
Maintain precise laboratory notebooks and complete all associated analytical reports, write summaries, and ensure proper documentation in compliance with Standard Operating Procedures (SOPs).
Additional duties related to departmental activities may be assigned by management as necessary.
Qualifications:
Education and Experience Requirements
Bachelor's Degree in Chemistry or a related scientific discipline with a minimum of 2 years of industry experience as a Chemist.
Master's Degree in Chemistry or a related scientific discipline with at least 1 year of industry experience as a Chemist.
Familiarity with current GMP guidelines, applicable USFDA and ICH regulations, and regulatory requirements (such as USP/ICH standards).
Ability to make observations using instruments and analytical techniques.
Basic understanding of instrumental techniques and software for instruments such as HPLC, GC, IR, and Karl Fischer titrators.
Capability to perform necessary calculations and interpret graphical data.
Basic knowledge of method validation, method transfer, and method verification of analytical methods.
Proficient in basic to advanced computer skills.
Physical Requirements
The physical demands of this position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking, and hearing.
Lupin Pharmaceuticals Inc. 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 demands of this position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking, and hearing.
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