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A senior executive with global experience and responsibility in building and leading diverse and matrixed teams in development and manufacturing organizations of biopharmaceutical drugs.
Especially skilled in orienting, developing and guiding teams to reach their fullest potential to meet corporate / client objectives.
Proven record with over 25 years of experience ensuring the delivery of biopharma products to the highest standards in Quality, Reliability and Cost through strategic leadership according to principles of the highest and uncompromisable integrity.
Strong business acumen and ability to develop innovative solutions that deliver significant business value to meet corporate / client objectives.

Prior Experience and Education

He is Associate Professor at the University Aix-Marseille teaching Quality, Process Industrialization, and Vaccinology
Alain has led the establishment of large-scale manufacturing using single-use technologies only to permit the parallel development of a significant lead portfolio consisting of multiple vaccines destined for the developing world encompassing Tuberculosis, Malaria, HIV, and Ebola vaccines.
Alain has led and supervised the transfer of a manufacturing process from. In the frame of this work, Alain was an early adopter of single-use technologies.
Alain holds a Master in Biochemistry and a PhD in Molecular and Cell Biology from the University of Berne, Switzerland

Recent projects highlights

He has built and supervised as SVP the Quality Department to BLA submission and Pre-Approval Inspection for Omisirge which was just approved by the FDA.
He has built and supervised as CTO the development of cell and exosome-based therapies which resulted in two CTAs within 18 months.
He has supported in Belgium the development of a mRNA manufacturing process scale up.
He was leading a 3-year Operational Excellence program establishing Toyota Production System principles in the development and clinical manufacturing of the two new vaccines for which the Clinical Phase 3 Trial material was manufactured under his supervision.
He was leading a 2-year Operational Excellence program to establish a comprehensive approach for the Technical Live Cycle Management of the entire Vaccine Portfolio.
Alain has created and built two companies: 1) Pharma-Consulting ENABLE; and 2) Science & Tech ENABLE GmbH

Jade is a bioprocess engineer who has joined Science & Tech ENABLE team since September 2022.
A bioprocess engineer working in set up operational quality systems in the biopharmaceutical industry.

Specialized in the development of biopharmaceutical processes from laboratory to manufacturing scale. The field of action ranges from new cellular therapies to the most classic monoclonal antibodies directed against all types of solid and liquid cancer.

Prior Experience and Education

After an intensive two-year post-baccalauréat course in Biology, Jade joined Polytech Montpellier, specializing in the agri-food industry.
Jade joined Polytech Marseille, an engineering school, and holds a Master in Biotechnology

Recent projects highlights

She has worked on the development of a cell therapy based on MSCs/iPSCs for the treatment of Chronic Obstructive Pulmonary Disease (COPD)
She has developed a process and analytical methods for an antigen purification for a vaccine a veterinary pharmaceutical company.
She has been supporting, a start-up developing exosomes in Phase II clinical trials, she is involved in the set-up and maintenance of QMS, supply chain and CMC systems.
Recently, she began managing CDMOs for the clinical launch of a start-up developing monoclonal antibodies used to treat cerebral hemorrhage.

A bioprocess engineer working in set up operational quality systems in the biopharmaceutical industry.

Specialized in the development of biopharmaceutical processes from laboratory to manufacturing scale. The field of action ranges from new cellular therapies to the most classic monoclonal antibodies directed against all types of solid and liquid cancer.

Prior Experience and Education

Morgane holds a Master in Biotechnology, Polytech Marseille engineering school
She has also a double Master in Experimental Strategies and Information Processing, Aix Marseille University
Morgane holds a Biological Associate’s degree in Food and Biotechnologies engineering

Recent projects highlights

She has been working on evaluating the performance of chromatography membranes to replace the resins currently used for monoclonal antibody purification. This innovative and promising technology will help to overcome a number of constraints on downstream process productivity.
For over a year now, she has been working on the set-up and maintenance of QMS, supply chain and CMC systems for a start-up developing exosome cell therapy in Phase II clinical trials.

Recently, she began managing CDMOs for the clinical launch of a start-up developing monoclonal antibodies used to treat cerebral hemorrhage.

Tiphaine is a junior bioprocess engineer who has joined Science & Tech ENABLE team since September 2023.
Currently set up operational quality systems in biopharmaceutical industry and the development of processes from laboratory to manufacturing scale.
She has technical expertise in biology, chemistry, pharmacology, project management and she demonstrates a good communication, while remaining flexible and ethical in her approach to helping companies succeed.

Prior Experience and Education

Tiphaine has obtained a Two-year university degree in technology, specialized in biology and biochemistry in La Rochelle
Tiphaine holds a Master in Biotechnology, Polytech Marseille engineering school

Recent projects highlights

She has a 2 years' experience as biochemist / polymerist in a R&D start-up in Montpellier where she designed bioinspired materials for bone tissue engineering and mesenchymal stem cell culture.
She also worked on an innovative nanovectorization strategy by functionalization of cage molecules and targeting compounds (antibodies, aptamers) and encapsulation of active ingredients for the treatment of colorectal cancer.
She contributes to the setting up of a CDMO and the installation of R&D and GMP laboratories
She develops production processes and analytical methods for cell & gene therapies, in particular the production of CAR-T cells and exosomes
She is drafting quality documents to obtain accreditations

Everything you need,

Available worldwide, we can support you in many areas, from quality to process improvement.