Pharmiweb | Analytical Consultant

Job Description 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: 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)