Brooke Ashleigh is an accomplished analytical problem solver who has extensive experience in regulated environments. As a master's degree holder in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University with Regulatory Affairs Certification (RAC) (US), Brooke has been expanding her compliance expertise in a regulatory-focused CMC role.

Brooke has over 10 years of laboratory experience in both pharmaceuticals and medical devices from her experience as a Senior Manager - Global Regulatory Affairs, CMC at Vertex Pharmaceuticals, where she writes SOPs, technical reports, test methods, and validation protocols in regulated environments. Brooke has experience operating and troubleshooting analytical instrumentation like HPLC, GC, KF, DSC, SEM, and more. Brooke has experience in cGMP analytical release and stability laboratories, and she worked as Supervisor - Quality Control, Analytical Sciences at Acorda Therapeutics, Inc., Senior QC Analyst at Acorda Therapeutics, Inc., QC Analytical Chemist at InVivo Therapeutics, Scientist II, Analytical Chemistry at 480 Biomedical, Inc., Sr. Scientific Associate, Analytical Development, GMP Release and Stability Lab (RSL) at Vertex Pharmaceuticals, and Scientific Associate II, Analytical Development at Vertex Pharmaceuticals.

Brooke Ashleigh is a problem-solver, innovative, collaborative, and able to adapt to fast-paced environments. She has gained extensive global regulatory affairs, CMC, and technical experience, making her an excellent candidate for a senior management role in the manufacturing and the pharmaceutical industry.