Seasoned CMC Analytical Development Expert
15 years of industry experience in analytical development and quality control with expertise in developing reliable analytical methods and control strategies to bring advanced therapies from research, clinical trials to commercialization. Broad working knowledge ranging from small molecules, DNA/RNA, peptides, biopolymers, to biologics. CMC experience includes development and regulatory strategy and implementation such as CDMO selection, specification setting, shelf-life assessment, reference material programs, and raw materials controls.
- Cell Therapies
- Combination Product
- DNA & RNA Therapeutics
- Small Molecules
Relevant Therapeutic Areas
- Genetic Diseases
- Rare Disease
- Director, CMC
- Associate Director, CMC Analytical Development
- Greater Boston Area
- Open to remote and in-office
- Nitto Avecia
- Small Biotechs
Skills & Accomplishments
- Experience with a wide range of modalities and dosage forms from starting materials, small molecules, oligonucleotides, peptides, polymers, cells, devices, sterile products, fresh products, and combo (ATMP) products.
- Successful track record of managing CDMOs and CTLs to complete CMC activities on-time: development runs/clinical/PPQ/PAI runs; phase-appropriate method development, transfer, and validation; stability program and reference materials etc.
- Method development and validation experiences across a wide range of analytical techniques (hands-on and management): UHPLC, HPLC, MS, IC, DSC, TGA, KF, UV, FTIR, RI, dissolution, disintegration, SPE, GC, ICP-MS/OES, biosafety (sterility, endotoxin, mycoplasma), ROI, LOD, microscope, viscometer, rheometer, texture analyser, FFF, SEC-MALS, etc.
- Authored and reviewed CMC sections in support of IND/IMPD, BLA/MAA, information requests, amendments, briefing books.