Senior Scientist

Central Jersey, New Jersey

  • Under the supervision of The R&D Manager or a Senior Scientist, develop analytical methods and improve existing ones to ensure that laboratory resources are optimized, while methods meet the objectives required to support all stages of drug development activities in the development and scale-up of generic and 505B2 formulations including parenterals (solutions and suspensions), and ophthalmic (solutions, suspensions and ointments) products from bench top to pilot-scale to commercial production.  This may entail technology transfer from other plants as well.

  • Conduct routine and non-routine laboratory analyses such as finished product testing, stability testing, and manufacturing in-process testing which require critical levels of accuracy using UPLC/HPLC,LC-MS, GC, GC-MS,ICP-MS and AA Spectroscopy, and other methodologies/instrumentation, including Empower 3 software.

  • Understanding with the concept of dissolution and drug release and using of dissolution apparatus USP 1, 2 and 4.

  • Awareness of the principle of Extractable and leachable and in laboratory.

  • Write standard methods of analysis.

  • Prepare and write technical reports, which summarize formulation development work and results.  Write and review analytical test methods, reports and protocols.

  • Operate all laboratory analytical instrumentation and perform troubleshooting and calibration of laboratory equipment as needed. 

  • Perform assigned various tasks which are needed to maintain the laboratory. Such tasks may include ordering lab supplies, calibrating instruments, and Hazmat duties.

  • Manage time effectively to complete assignments in an expected time frame.

  • Document all experimental work neatly and correctly in a lab notebook in accordance with Standard Operating Procedures.

  • Review lab testing results and notebooks to ensure accurate documentation.

  • Ensure proper training before performing any tests and maintain an up to date training record related to all job functions and GXP requirements.

  • Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.               

  • Maintain quality checks on safety of the Lab, including biohazards and insure maintenance of the facilities according to Good Laboratory Practices.