Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic
Alessandra Ambruosi

Alessandra Ambruosi

Summary

Results-oriented R&D leader with 20 years of experience in pharmaceutical development. Specializes in orally administered drugs and solid dosage forms. Proven track record of leading high-performing teams, driving product innovation, and managing complex projects within the pharmaceutical industry. Committed to fostering a collaborative and progressive work environment, ensuring adherence to quality and regulatory standards.

Overview

19
19
years of professional experience

Work History

Director, Head of R&D Solid Formulations

Merck Life Science
08.2020 - Current
  • Spearhead the development and execution of an innovation pipeline for new excipients and technologies in solid dosage forms, with a focus on poorly soluble drug substances, predictive formulation models and continuous manufacturing.
  • Lead the exploration of advanced technologies for the oral delivery of small molecules and peptides, including PROTACs and GLP-1 analogues.
  • Oversee a diverse team of 25 professionals across Darmstadt, Mumbai, and Shanghai, ensuring effective collaboration and high-quality product development.


Key Achievements:

  • Successfully launched five new products, including an innovative software solution for co-crystal predictions, a specialized polymer designed to enhance the solubility of NCEs, and a novel filler-lubricant blend optimized for continuous manufacturing processes.
  • Obtained IVC approval and led the establishment of a new technology center in Mumbai, which successfully opened in February 2025.

Laboratory Manager, Chemical & Pharmaceutical Development

Merck Healthcare
09.2015 - 07.2020
  • Managed the development and manufacturing of solid formulations for clinical supply in compliance with quality and regulatory standards.
  • Acted as CMC leader for a phase I development project.


Key Achievements:

  • Made substantial contributions to the launch of Mavenclad by preparing pharmaceutical development documents for health authority submissions.
  • Streamlined phase I clinical trial development by successfully formulating and delivering tablets for the 'First Patient In'.

Project & Innovation Manager, Parenteral Nutrition

Fresenius Kabi
01.2012 - 08.2015

Global Project Manager

UCB
06.2008 - 12.2011

Team Leader, Drug Product R&D

Schwarz Pharma
04.2006 - 05.2008

Education

Ph.D. - Pharmaceutical Technology

Wolfgang Goethe University
03.2006

Study - Pharmaceutical Chemistry and Technology

University of Pharmacy
04.2002

Skills

  • Expertise in the development of orally administered drugs, including New Chemical Entities (NCEs)
  • Strong leadership and team management capabilities
  • Proficient in digital and data-driven tools for predictive development
  • Excellent stakeholder management and collaborative skills

Languages

English: Fluent
German: Fluent
Italian: Native
Spanish: Intermediate

Timeline

Director, Head of R&D Solid Formulations

Merck Life Science
08.2020 - Current

Laboratory Manager, Chemical & Pharmaceutical Development

Merck Healthcare
09.2015 - 07.2020

Project & Innovation Manager, Parenteral Nutrition

Fresenius Kabi
01.2012 - 08.2015

Global Project Manager

UCB
06.2008 - 12.2011

Team Leader, Drug Product R&D

Schwarz Pharma
04.2006 - 05.2008

Study - Pharmaceutical Chemistry and Technology

University of Pharmacy

Ph.D. - Pharmaceutical Technology

Wolfgang Goethe University
Alessandra Ambruosi