The world’s largest pharmaceuticals market is also the biggest market for Sun Pharma. 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.
Has knowledge of commonly used concepts, practices, and procedures within the pharmaceutical field. Follow instructions and pre-established guidelines to perform the functions of the job. Works under minimal supervision.
Essential Job Functions:
Under the direction of laboratory management, this individual:
Performs review/audit of lab notebooks, analytical data, and analytical reports. Possess a demonstrated ability to write scientific reports.
Demonstrates a thorough knowledge of approved SOP’s, compendia, ICH, FDA and other regulatory guidelines.
Ensures that all documents are in compliance with cGMPs and the site operating procedures under the direction of senior staff or laboratory management.
Performs testing of API, Finished Product, process validation samples, cleaning validation samples, and stability samples using a variety of standard & advanced analytical techniques.
Assists in conducting analytical method validation and method transfer activities as directed.
Assists in preparing technical documentation including test reports, analytical test procedures, and change controls.
Supports systems to ensure the successful completion of departmental goals and objectives.
Has exposure to the basic theory and operating principles of HPLC, UV, FTIR, GLC, and Malvern particle size analyzers.
Has the initiative/drive to participate in a leadership capacity in one or more of several laboratory committees (e.g. Safety, Instrumentation, GMP, SOP, etc.)
Performs all job responsibilities in a safe and efficient manner.
Performs other duties as assigned.
B.S. or advanced degree in chemistry or a related science with a minimum of five (5) years experience and a fundamental knowledge of various instruments and wet chemical analytical techniques used in pharmaceutical analysis is preferred.
Good written and oral communication skills. Documented ability to perform routine laboratory assignments and non-routine projects with minimal supervision within the framework of cGMP/GLP for analytical laboratories and EHS/OSHA laboratory safety guidelines.
Several years of experience in chromatography (e.g. HPLC with Empower data acquisition software, GC, FTIR, UV, and wet chemistry)
Knowledge of ICH, FDA, and DEA regulations.
Must be able to work independently.
Proficient in the ability to read/write and comprehend complex instructions, correspondence, and memos. Have the ability to effectively present information in a one-on-one or group situation.
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.
While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear. The employee is frequently required to stand, walk, sit and stoop, kneel, crouch, crawl, push, and bend.
Must be capable of bending and lifting, moving and/or carrying approximately 50 pounds.
Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
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.
Must have English language fluency, both written and verbal, with the ability to communicate at all levels within the organization.