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Micol SantiMS
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Micol Santi

@micolsanti

Process development scientist at CureVac who optimized mRNA-LNP manufacturing and transferred processes to GMP facilities.

Germany
Message

At CureVac SE, I lead process development activities from early R&D through late-stage clinical manufacturing. I define experimental strategies and contribute to CMC documentation, including CTD Module 3 development sections and specifications.

As a Scientist I at CureVac SE, I optimized mRNA-LNP manufacturing processes and designed experiments from feasibility studies through DoE campaigns. I also coordinated technology transfer to internal GMP facilities and external CDMOs, supporting troubleshooting, risk assessments, and control strategies.

At IOCB, Bielefeld University, I developed continuous-flow biocatalytic reactions and translated enzymatic transformations from batch to flow with a Python-empowered optimization loop. During my Ph.D. at Cardiff University, I applied flow chemistry and Design of Experiments to reaction monitoring and optimization.

I’m a qualified CMC Specialist with a Ph.D. in Organic Chemistry and a degree in Chemistry and Technology of Drugs. My work includes providing scientific and technical guidance on process development, material qualification, and manufacturing requirements.

Experience

Work history, roles, and key accomplishments

CureVac SE logoCS
Current

Scientist II Process & Pharmaceutical Development Drug Product

CureVac SE

Apr 2025 - Present (1 year 7 months)

Lead process development activities from early R&D through late-stage clinical manufacturing, defining experimental strategies and technical deliverables. Provide technical expertise for process optimization, root-cause investigations, and manufacturing-related decisions.

CureVac SE logoCS

Scientist I Process Development Drug Product

CureVac SE

Jan 2022 - Apr 2025 (3 years 3 months)

Optimized mRNA-LNP manufacturing processes with hands-on expertise in formulation, tangential flow filtration, and filtration. Designed and executed experiments from feasibility to DoE campaigns to support Phase I-III clinical development.

IU

Postdoctoral Research Associate

IOCB, Bielefeld University

Jan 2021 - Dec 2021 (11 months)

Developed continuous-flow biocatalytic reactions, translating enzymatic transformations from batch to flow integrated with a Python-empowered optimization loop.

Education

Degrees, certifications, and relevant coursework

FM

FORUM Institut für Management

CMC Specialist Qualification, CMC

Qualification as CMC Specialist from FORUM Institut für Management.

SA

Sartorius

Design of Experiments (DoE) with MODDE®, Design of Experiments

Training in Design of Experiments (DoE) with MODDE® from Sartorius.

CC

Council for Six Sigma Certification

Lean Six Sigma Yellow Belt Certification, Lean Six Sigma

Lean Six Sigma Yellow Belt Certification from the Council for Six Sigma Certification.

University of Michigan logoUM

University of Michigan

Python Specialization, Python Programming

Python Specialization from University of Michigan eLearning via Coursera.

Loughborough University logoLU

Loughborough University

Enabling Technologies Summer School, Enabling Technologies

Enabling Technologies Summer School from Loughborough University.

Cardiff University logoCU

Cardiff University

Doctor of Philosophy, Organic Chemistry

2016 - 2020

Activities and societies: Supervised undergraduate students in practical organic chemistry laboratory courses and supported examination marking.

Ph.D. in Organic Chemistry from Cardiff University, with thesis on novel applications of α-diazocarbonyl compounds and enabling technologies in stereoselective synthesis.

Università degli Studi di Perugia logoUP

Università degli Studi di Perugia

Degree, Chemistry and Technology of Drugs

2010 - 2016

Grade: 110 cum laude/110

Degree in Chemistry and Technology of Drugs from Università degli Studi di Perugia, with a grade of 110 cum laude/110.

Tech stack

Software and tools used professionally

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