I am recruiting an experienced Analytical CMC Consultant to join one of my biopharmaceutical clients on a 6 month contract. The ideal candidate will provide SME analytical expertise and support for key analytical activities (including authoring analytical sections of IND's/BLA's). 

Key Responsibilities:

1. • Support the characterization including the development of analytical strategies and methodologies to assess product quality.
   • Provide expertise in the validation and transfer of analytical methods.
   • Collaborate with internal teams to ensure alignment of methods with regulatory requirements and industry standards.
   • Lead activities related to the qualification of reference standards for Biological products.
   • Provide analytical support for both Drug Substance (DS) and Drug Product (DP) processes.
   • Write and author analytical sections (source reports) 

Qualifications:

• • Analytical SME background for Biologicals (5 + years)
  • Proven expertise in the characterization of biopharmaceutical products and reference standard qualification.
  • Strong background in analytical method validation and transfer.
  • Experience in authoring analytical CMC sections of a BLA (BLA filing experience required)