AR&D Chemist II/Analytical Research Chemist II
The world’s largest pharmaceuticals market is also the biggest market for Sun Pharmaceutical. We have been present in the US since 1996, working with the country’s healthcare system with a focus on generics, branded generics and over-the-counter (OTC) products. We are valued suppliers to the largest wholesalers, distributors, warehousing and non-warehousing chain drugstores and managed care providers. Being a vertically integrated company with a global presence, we have the flexibility to develop and manufacture products in the US as well as at other locations across the world. Our US headquarters is located in Cranbury, New Jersey and we have manufacturing, distribution and customer service teams at multiple locations across the country.
Job Summary: ?
? Perform analytical testing for drug substances and various drug products such as tablets and capsules. Operate instruments such as HPLC, GC, Dissolution, Particle Size, and KF titrator. Prepare SOPs, specifications, and method of analysis. Interpret the analytical data. Assist in method transfer and validation.
Essential Job Functions:
Perform routine analytical tests of pharmaceutical raw materials, in-process samples, blends, finished products, and stability samples using instrumentation such as HPLC, UPLC, GC, UV/VIS, FTIR, dissolution apparatus, particle size analyze, etc.
Responsible for the timely execution of lab analysis and related documentation.
Concurrent documentation of all the raw data and record observations in the worksheets/templates/notebooks.
Be vigilant to any difficulties, undesirable/unacceptable problems in analytical method execution, chromatography, and data integration and keep the supervisor informed of such issues.
Compile, understand and interpret the R&D analytical data and n otify the supervisor of any anomalous observation.
Keep the working place clean and tidy.
Create and maintain clear and concise lab records and documentation (notebooks and computer-based).
Perform routine maintenance of lab equipment as needed.
Adhere to safety, DEA procedures, and department SOPs.
?Perform other duties as assigned.
? Bachelor of Science and/or Master of Science in Chemistry with a minimum five years of experience in a pharmaceutical analytical laboratory.
Must have strong skills in method development ?and method validation.
Familiar with analytical instrumentation and wet chemistry techniques.
Well versed with Microsoft Office applications.
Excellent knowledge of cGMP and/or GLP practices and regulatory guidelines.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job in an office or manufacturing environment. The noise level in the work environment is usually moderate.
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.
Must be capable of bending and lifting, moving and/or carrying approximately 50 pounds.
Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.
Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
Must have English language fluency, both written and verbal, with the ability to communicate at all levels within the organization.