Associate Scientist II, Analytical Chemistry

Lake County, IL, US
Jul 18, 2019
Required Education
Masters Degree/MBA
Position Type
Full time
T he New Chemical Entity Drug Product Development Analytical Group is responsible for developing and validating analytical methodologies for both active pharmaceutical ingredient (API) and drug product to enable clinical trials, toxicology studies and drug product development for Abbvie's pre-clinical and clinical candidates. The Analytical Group is also responsible for Chemistry Manufacturing Controls (CMC) support from first in human trials through NDA/MAA application. Its laboratories operate under both Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to enable release of materials for pre-clinical and clinical studies respectively.

Key Responsibilities Include:
  • Generate accurate, reliable data by following established practices and procedures.
  • Maintain laboratory in orderly and compliant manner. Learn and effectively implement new experimental protocols and/or techniques.
  • Understand scientific purpose of assignments. Ensure safety and GxP requirements are met when performing tasks. Maintain conformance with cGXP through compliance and documentation. Recognize and report experimental variances.
  • Resolve scientific/technical issues/problems.
  • Operate, maintain and troubleshoot instrumentation and equipment.
  • Demonstrate basic understanding of mass spectrometry and proficiency in the use of HPLC-MS.
  • In addition, the ideal candidate will demonstrate familiarity with data integrity requirements (i.e., MHRA and FDA final guidances) and remediation and qualification strategies for instrumental data acquisition / processing systems to meet data integrity expectations.
  • Write and revise quality system procedures and/or business practice documents.

  • Bachelor's Degree, or equivalent education, with typically 3 or more years' experience or Master's Degree or equivalent education (no additional experience.
  • Theoretical and practical knowledge to carry out job function .