KELLY SOREL

** ****** **, ***** **, ***** · 617-***-**** · ad2sge@r.postjobfree.com

EDUCATION

MASSACHUSETTS INSTITUTE OF TECHNOLOGY, Cambridge, MA Jun. 2021

Master of Applied Science in Supply Chain Management

Supply Chain Management Program

OHIO UNIVERSITY, Athens, OH 2000 – 2004

Bachelor of Science: Chemistry & Biochemistry Department

Major: Forensic Chemistry

EXPERIENCE

WAVE LIFE SCIENCES, Lexington, MA Jul. 2021 – present

Associate Director, Clinical Supply Chain

Provided sole operational oversight to ensure timely delivery of released and approved IMP and ancillaries for all clinical trials. This included:

-Collaborating with CMC, Global Supply Chain, Regulatory, Clinical Operations, Quality, and Project Team customers

-Forecasting demand

-Overseeing availability of IMP and ancillaries at depots and sites

-Performing selection, set-up, and management of IRT, Drug Distribution, and Translation vendors

-Managing temperature excursions and any other quality-related topics

Developed and maintained IMP labels and Pharmacy Manuals for all clinical trials

Identified requirements for site pharmacies, and vetted pharmacies for participation in clinical trials

Acted as SME during regulatory inspections

Collaborated on SOP development and process improvement

SANOFI, Framingham, MA Feb. 2017 – Jun. 2021

Clinical Supply Chain Project Leader

Led Clinical Supplies Project Team, which included up to 15 representatives from demand planning/material movement, trial supply operations management, quality and packaging/labeling. Notable projects included:

-A top 5 company priority project with 5 rare disease indications and seven Phase 1, two Phase 2, and twenty-two Phase 3 trials in the clinical development plan

-Post-market global pediatric study for a top 3 profitable drug for company

-21 externally-sponsored research studies, requiring collaboration outside of Sanofi

Represented Clinical Supplies at the Project Team level and within CMC team; acted as a single interface with regulatory, clinical operations, quality and project team customers

Generated service agreements (containing technical specifications for packaging/labeling, IMP demand, timelines and related costs); managed any change impacting the allocated budget; revised business plan and service agreement accordingly

Directed risk management, which required leadership and a comprehensive understanding of the disease indication, trial design and specificities to the drug and patient population. This included:

-Understanding of all regulatory activities required due to changes in clinical study design, CMC attributes, and/or guidelines

-Pro-active planning and implementation of back-up plans

ALNYLAM, Cambridge, MA Aug. 2014 – Jan. 2017

Supply Chain Planner

Coordinated IMP for multiple global clinical trials, requiring management of label creation, packaging/labeling and distribution

Communicated and updated clinical supply requirements on a study and project level to Supply Chain Management, and ensured seamless coordination of demand and supply through partnerships with quality and clinical operations

Ensured changes in supply configuration, trial design, enrollment timelines, manufacturing availability and regulatory requirements were captured within the supply and demand plan

Developed strong internal relationships with stakeholders to ensure customer satisfaction and continuity of supply

SHIRE HUMAN GENETIC THERAPIES, Lexington, MA Nov. 2006 – Aug. 2014

Senior Planner

Production Control Specialist

Manufacturing Technician

ACHIEVEMENTS

MITx MicroMasters program certificate

-MITx MicroMasters program in Supply Chain Management, Massachusetts Institute of Technology on edX

Developed competency in Supply Chain theory and practice through 500 hours of online coursework

Created models and solved problems in SC analytics, design, dynamics and related technologies

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