How I can best support you...

My expertise spans all facets of analytical operations, including method lifecycle management, characterization, comparability, identification of CQAs, and technical writing.  As your partner, I can drive assurance that analytical methods are well-understood, fit for purpose, and robust.  I have a great deal of experience in the selection and implementation of analytical techniques across in-process, release, and stability testing to support well-designed control strategies that ensure product quality and patient safety.

I have led methods through development, qualification, transfer, and remediation activities, as well as validation, verification, and trending activities to ensure optimal method performance and monitoring.

The execution, interpretation, and documentation of detailed characterization studies are critical to product understanding and a core component of the regulatory submission. I bring a depth of experience in the evaluation of primary, secondary, tertiary, and higher-order structures, post-translational modifications, thermal stability, the assessment of size, charge, and hydrophobic variants including characterization of minor species, as well as biological properties. Additionally, I have led the design of forced degradation studies that form the basis of understanding the pathways by which a product degrades and identifying 'hot spots' susceptible to modification.

Developing comparability protocols and associated prospective acceptance criteria form another area that I can support for your biotherapeutic programs.  I can oversee execution and data analysis and ensure thorough documentation of comparability results.

I bring experience both in leading internal Quality Control operations and also with the selection, oversight, and direction of external third-party vendors, both in the US and also international partners in Europe and Asia.  

I have established and led stability programs, managed reference standards, and maintained processes for critical reagent supply.  I can assist in the generation and review of standard operating procedures to ensure that these business processes are optimized and phase-appropriate while adhering to regulations.  I also provide input into laboratory investigations and deviations, as well as their overarching procedures.

A key strength that I bring to my clients lies in my expertise in authoring technical documents and my ability to generate content for regulatory filings.  I have broad experience in successful submissions for CMC content across Drug Substance and Drug Product sections from first in human to licensure.