Analytical Development Scientist


Birmingham, AL


Job Function Summary:

The Analytical Development Scientist is responsible for routine laboratory analysis of raw materials, in-process materials, finished products, stability and process validations associated with the development and submission of drug products. The candidate must demonstrate experience working in a cGMP laboratory and possess broad knowledge of industry regulations related to pharmaceutical analytical analysis.

Core Responsibilities:

  • Perform routine, method and process validation analyses according to company established Standard Operating Procedures (SOP’s), Current Good Manufacturing Practices (cGMP’s), Good Laboratory Practices (GLP’s), Good Documentation Practices (GDP’s), as well as FDA/DEA/OSHA regulations.
  • Follow regulatory guidelines and compendia pertaining to laboratory analyses, method validation, verification, and transfer.
  • Troubleshoot methods or instruments, HPLC and (or) UPLC, using Empower 3 software. Must be able to analyze and interpret data from Empower 3.
  • Complete all projects in a timely manner, to ensure Safety, Quality and Customer Service.

R&D Specific Requirements

  • Ability to think beyond routine analysis of samples to detect issues with the method, product, or instrumentation
  • Basic knowledge of USP/NF, Product Stability requirements, and Process and Method validation.
  • Ability to integrate into team-based projects
  • Experience with laboratory instrumentation such as HPLC, Dissolution Bath, GC, Karl Fischer titrator, UV/Vis, and FT-IR Spectrometer.
  • Strong interpersonal communication and writing skills
  • Competency in Microsoft Office Suite
  • Ability to work under minimal supervision

Physical Requirements

  • Ability to wear personal protective equipment (safety glasses, respirator, gloves, etc.)
  • Ability to stand for long periods of time
  • Ability to lift/carry 10-15 lbs.

Education and Experience

  • BS or MS in chemistry, organic chemistry, or biochemistry
  • Minimum of 2 - 3 years relevant experience in an analytical laboratory

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