Specialist, Commercial Stability

  • Contract Duration: 6+ months, potential to extend or convert to FTE
  • Miscellaneous
  • Boston, MA

Website Lenox Executive Search

Description

Lenox Executive Search is seeking a Specialist, Commercial Stability for one of our global pharmaceutical clients, hybrid in Boston, MA. This is a six-month contract with possible extension and/or conversion to FTE.

KEY RESPONSIBILITIES of a Specialist, Commercial Stability:

  • Support maintaining compliance of the commercial stability program, which encompasses all commercial products/strengths including starting materials, drug substance intermediates, drug substance, drug product intermediates, and drug products.
  • Transfer stability data from external contract testing laboratories to internal systems.
  • Support entry of stability data into Laboratory Information Management Systems (LIMS) as well as verification of stability data entries.
  • Effectively communicate with internal and external stakeholders

EDUCATION AND EXPERIENCE of a Specialist, Commercial Stability:

  • A minimum of a bachelor’s degree in science or related discipline is required.
  • 2 years of experience in pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience
  • Basic knowledge and understanding of analytical methodologies such as chromatography, dissolution, water content, and physical from data
  • Experience with electronic document management systems
  • Experience with Laboratory Information Management Systems (LIMS)
  • Experience with statistical software and its application to support data entry
  • Knowledge of US and EU cGMP regulations/guidance.
  • Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
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