Julien Massiot

- Early-stage process development of novel linker-payloads - Process transfer to CDMOs and operational CMC project management (including manufacturing and analytical activities) for all the ADC components (Linker-Payload, mAb and ADC DS and DP) - Preparation of CMC regulatory documentation (pre-IND, IND and IMPD)

- Operational CMC project management (manufacturing & supply, analytical, and formulation) - CMC regulatory documentation preparation/submission for clinical development

- CMC regulatory documentation preparation for clinical and commercial development - Interface between Manufacturing/Quality activities and regulatory department - Change control CMC regulatory evaluation

Leads to Development ensures preclinical studies operational management, as well as regulatory dossier preparation for its clients (Biotech companies). As a senior project manager, I take care of: - CMC and non-clinical operational project management: acts as an interface between clients and service providers (both CROs and CMOs) - Writing regulatory documentation: scientific advice briefing documents/pre-IND, IB, IMPD, IND, BLA, MAA

Institut Galien Paris-Sud (UMR 8612) Member of Physical Chemistry department • Development and study of bio-inspired lipid nanomedecines for light-triggered drug delivery applied to cancer treatment • Project part of the program "Therapeutic innovations: from fundamental research to applications"

Part of the team of chemistry, and in parallel to my PhD, this mission is to make science more easy to approach for younger people, or people outside the world of science. Through series of presentations, specific experiments are produced for audience to explain better what's hidden behind the word "Chemistry", and what's the role of Chemists in our society.

• Development of lipid nanodiscs (cells' membrane mimicking system) for analysis of membrane proteins. • Innovative strategy in order to understand proteins interaction and determine protein structure and conformation, mostly using solution and solid-state NMR

•Take part of the Analytical Department routine work, included pharmacokinetic (pK) study of various number of drugs, encapsulated in liposomes. •Conduct a project consisting in the study of prostaglandins, by developping an analytical method based on a on-line SPE-LC-MS/MS

Working as an intern in the Hair Care department •Study of Hydrophobicity and swelling behaviour of Hair Fibers •Development of different methods of statistical analysis on digital microscope.

Conducted research in the Genomics Research Center of Academia Sinica • Label free mass spectrometry based-proteomics on Stem cells and iPS (Induced Pluripotent Stem) cells • OffGel electrophoresis pre-fractionation

Specialized in Analytical Chemistry (major); and Chemistry for Health (Minor) Theoretical classes, given both in French and English, include topics as the separation and characterization techniques, bioanalytical specific methods, mass spectrometry, and biological process applied to chemistry. One week of practical training, every two weeks, is conducted and consists in developing different analysis techniques and methods in the lab, using HPLC, GC, LC-MS, Electrophoresis, and so on.