Maxime Diem Email & Phone Number

Fribourg, Fr, Ch

Fribourg, Switzerland

Cressier, Fribourg, Switzerland

Epalinges, Vaud, Switzerland

Position as Group Leader of the Quality Control (QC) team to ensure the operational efficiency and continuous improvement of the QC department in accordance with the internal quality management system and ISO 13485.Main activities:- Plan QC activities for raw materials, intermediates, and finished products.- Coordinate QC activities with Production team to ensure compliance with product release schedule.- Manage and supervise operational activities of QC technicians.- Manage training of QC technicians.- Review traceability reports and approve QC test results.- Root cause analysis of non-conformities in close collaboration with Production and Industrialization.- Drafting, analysis and treatment of deviations, non-conformities and CAPA in close collaboration with Quality Assurance.Achievements:- Improvement of the QC team cross-collaboration with Production, Industrialization and QA teams.- Improvement of QC key performance indictors.- NC backlog cleared, from ~10 NC overdue in the pipe to 0 NC overdue- Implementation of a new NC processing to avoid overdue recordss.- Stock management improvement by tracking consumable use on a daily and incorporation of QC stock in ERP system for a better control.

Epalinges, Vaud, Suisse

Industrialization engineer position in the industrialization department to ensure new product compatibility with current and future manufacturing processes in accordance with the internal quality management system and ISO 13485 standard with a focus given on QC method improvement.Main activities:- Focus given on QC methods improvement (data analysis, determination of improvement points)- Side project for a database creation to compiles QC and Production process data.Achievements:- Rework of two spectrophotometry QC method to assess fluorochrome/tag labelling on the Ab probe with implementation of new validity criteria, training of QC technicians with the updated procedure- Implementation of the QC and Production database on Excel and implementation of QC and Production KPI dashboard on PowerBI.

Fribourg, Switzerland

Bioprocess Training Instructor position to give training programs for pharmaceutical companies that covers both basic and advanced concepts in the areas of DSP (Downstream Processing) and GMP (Good Manufacturing Practice). The program is designed to equip participants with a comprehensive understanding of these key areas in the pharmaceutical industry, including best practices and basic regulatory requirements. The goal of this training is to provide participants with the skills and knowledge necessary to succeed in the biopharmaceutical and pharmaceutical industry.

Eysins, Vaud, Switzerland

Technology transfer scientist position in the newly created Technology transfer department. Responsible for ensuring transfer of purification and formulation processes for both Ab and Ag from R&D scale to GMP manufacturing scale as part of a multiplex IVD microarrays project for immunohematology and disease screening.Main activities:- Implementation of new processes and product documentation for GMP manufacturing activities- Technician team training on new processes.- Coordination with R&D, project management, manufacturing, and QA for project progressionAchievements:- Immunohematology project: ~20 Ab probe specifications updated.- Disease screening project: ~5 Ag probes technology transfer project progressed.- Participation of technology transfer department policy elaboration- Improvement of R&D material reception process

Eysins, Suisse

Associate bioprocess scientist position in the Bioprocess department. Responsible for ensuring manufacturing support and technology transfer activities as part of a multiplex IVD microarrays project for immunohematology.Main activities:- Review manufacturing batch record for purification and formulation processes.- Progress QA records related to manufacturing activities (Non-Conformity, Change control, Deviation).- Support tech transfer activities (Review of development reports, support development activities at manufacturing scale).- Conduct continuous improvement project for manufacturing purpose.Achievements:- Internal waterloop process implemented.- Numerous purification method reworked (AKTA/Unicorn).- Numerous NC and change control progressed and treated for Ab purification process.- Numerous manufacturing batch record review for Ab purification process

Fribourg, Suisse

Temporary contract that focus on a training program aimed at individuals looking to enter the bio-pharmaceutical industry and focuses on teaching the USP/DSP processes commonly used in the field. The objective is to equip participants with a comprehensive understanding of the key principles and practical applications of these essential processes, enabling them to effectively contribute to the development and production of life-saving treatments. The program covers both theoretical and practical aspects, providing hands-on experience with real-world scenarios and providing a thorough understanding of the industry's best practices (GMP and GDP).

La Chaux-De-Fonds, Neuchâtel, Suisse

In this role as a research officer, the focus was on the development of DSP processes for bi-specific antibodies and IgG projects. The main activities included the development of a chromatography purification step, generation and improvement of AKTA methods, analysis of chromatogram results, and generation of development reports. In addition, the responsibilities also included a review of the scale-up batch record in compliance with GMP standards, and review of the technology transfer plan and report. Significant achievements in this role included the development of a CEX chromatography step for a bi-specific project, and the review of the DSP technology transfer package for a 1000L scale-up.

La Chaux-De-Fonds, Neuchâtel, Suisse

Temporary contract as a DSP research officer in the DSP process developement team with a focus on compiling data for a biosimilar antibody project.

Illkirch-Graffenstaden

During this laboratory internship in Dr SUMARA team, I assisted in demonstrating UBASH3B (a cell cycle protein) as a promising therapeutic target for cancer. The findings showed that reducing UBASH3B levels increases death in a specific cancer cell population and three molecules were identified as potential therapeutic candidates.

Strasbourg

I secured a temporary contract with the Dr GAUB team, where I was responsible for developing a shared protocol between the molecular biology and biochemistry laboratories. I also collected samples of blood, bone marrow, and solid tumors, and carried out DNA extraction procedures.

Illkirch-Graffenstaden

During my lab internship in Dr CHARVIN team, I played a role in the creation of a Megawhop, a single-step modular plasmid cloning method. As a result, we successfully accomplished unique and targeted integration of the plasmid into the S.cerevisiae yeast genome. Additionally, using PCR, we generated 6 new modules, increasing the potential number of expression plasmids to 96 for a library of 14 modules.

Illkirch, France

Lab internship where I participated in improving the understanding of the role of the enzyme RAL-1 in exosome secretion in C.elegans. This study found that RAL-1 is essential for fusing the exosome-containing vesicle to the cytoplasmic membrane. Published in The Journal of Cell Biology (Hyenne et al., 2015).

Strasbourg , France

Temporary contract with the Dr GAUB team, where I was responsible of DNA extraction of solid tumors.

Strasbourg , France

Lab internship in Dr GUENOT team, focused on identifying micro-RNAs capable of regulating E2F2 and ID3 genes in colon cancer. Tasks included relative expression quantification of E2F2 and ID3 using RT-qPCR and of miR24, miR34a, miR106 and miR29b.

Strasbourg , France

Lab Internship in DR GAUB team focused on researching mutations of the CTNNB1 gene in desmoid tumors.

Master'S Degree, Biologie Cellulaire Et Moléculaire

Licence Professionnelle, Biotechnologie

Brevet De Technicien Supérieur, Biotechnologie