The qualified candidate will take an active role in supporting drug development by applying a variety of analytical methodologies to support physical and chemical characterization of drug substances (including raw materials and intermediates) and drug products. Working knowledge of analytical (e.g., HPLC-UV, HPLC-MS, GC-MS, spectroscopy) and physical chemical techniques (e.g., particle size, dissolution) used for the characterization of pharmaceutical substances and products is desired. Hand-on experience in HPLC method development is highly desired. Position level varies from bench chemist to principle scientist, depending on experience.
Principal Responsibilities:
The individual will be responsible for performing laboratory work in support of analytical testing of pharmaceutical projects, and relevant experience with the following analytical methodologies: chromatography, dissolution, KF, particle size will be desirable. Job responsibilities may include analytical method development and validation; stability and release testing; testing to support pharmaceutical development efforts; direct interaction with project team members, including presentation of data; critical review of data; preparation of technical reports; and evaluation of new instrumentation or analytical techniques. The candidate must be able to interact effectively with peers and leaders as part of a multi-disciplinary team and work in a fast-paced environment. Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.
Qualifications
The position requires a B.S, M.S. in Pharmaceutical Chemistry, Analytical Chemistry, Chemistry, or Pharmaceutical Sciences with relevant working experience in pharmaceutical industry.
Working knowledge in analytical method development and validation under cGMP environment.
Experience with a wide-variety of software and information systems (e.g. Empower, ChemStation, or LIMS).
Experience in problem-solving skills and instrument trouble-shooting.
Good oral and written communication skills and the ability to write and review technical reports and scientific papers are desired.
Working knowledge of pharmaceutical product development, CMC regulatory requirements, project management; and capability to collaborate with colleagues.
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