Camille Chaumien

Lead System Designer for automated Cell & Gene Therapy platforms. I lead architecture definition and systems engineering for complex R&D programs, bridging the gap between biological needs and technical execution. KEY ACHIEVEMENTS: Robotics Integration & Architecture Strategy (Context: Adaptation of instruments for the Cellular Origins robotic platform) - Architectural Reframing: Shifted the design strategy from a component-level focus to a holistic subsystem approach. This proactive re-scoping was designed to mitigate critical integration risks and is projected to significantly reduce future design iterations. - Reliability: Defined reliability strategies to ensure standard lab instruments could withstand 24/7 continuous robotic operation. Automated Platform Development (Context: Collaboration with Bayer on an allogeneic cell therapy platform) - Translating Biology into Engineering: Converted ambiguous biological user needs into measurable engineering targets (e.g., shear stress limits) using CFD and rapid prototyping. This secured technical decisions early, without waiting for late-stage biological testing. - Distributed Leadership: Aligned technical teams across the USA, Europe, and India, maintaining program velocity despite resource fluctuations. - Innovation & IP: Contributed to the generation of intellectual property, leading to the filing of patent applications related to bioreactor performance and cell processing. Systems Engineering Enablement - Internal Consultant & Mentor: Served as the site’s Subject Matter Expert on Systems Engineering for 4 years. - Ad-hoc Guidance: Mentored technical leads and project teams on Requirements Engineering and Design Control. Directly supported the transition from start-up habits to a structured QMS-driven development culture.

Focus on Requirements Engineering, Design Control, and Product Care. - Requirements Management: Managed traceability and design inputs for cell processing equipment (CAR-T therapies) in a highly regulated environment. - Design Control: Supported the engineering team in applying rigorous V-model practices during the transition from a start-up mode to a corporate QMS structure. - Audit Support: Acted as back-office support for MDSAP audits, ensuring technical documentation readiness. - Usability: Defined validation plans and procedures, ensuring compliance with usability standards.

Systems Engineer for Blood Grouping Solutions (IVD). Focused on Design Control, Regulatory Compliance (IVDR), and Usability Engineering. KEY ACHIEVEMENT: IVDR REMEDIATION - Managing Complexity: Led the definition of design-input requirements for a portfolio of 90+ immunohematology reagents under tight regulatory deadlines. - Strategic Alignment: Structured a modular requirement architecture to handle portfolio diversity, successfully aligning stakeholders and delivering a compliant, regulator-ready Design History File (DHF) where none existed before. ADDITIONAL RESPONSIBILITIES: - Usability Engineering: Defined Usability procedures and led validation plans in accordance with IEC 62366. - Design Control: Managed traceability matrices and design reviews for blood testing automates.

R&D Team Lead & Fluidics Expert (Start-up to Scale-up environment). Evolution from hands-on Engineer to R&D Team Lead following the acquisition of Symbion by Day Medical. - R&D Leadership: Led the Hardware Development and Integration/Validation teams. Followed Agile methodologies to structure the development process. - Technical Expertise (Fluidics): Developed innovative di-phased fluidic systems for microliter pipetting and reaction chambers, eliminating contamination risks. - Quality System: Revamped Design Control procedures to support the company's ISO 13485 certification.

Diploma Project: “Software and Electronics for a Flowing water NMR Magnetometer”, Supervisor G. Boero, LMIS1, EPFL In order to create an industrial innovative magnetometer, had to complete and enhance a pre-existing prototype. Had to simplify its functioning and automate the process of field magnitude research. Results: • Could create a RF oscillator which would replace an industrial function generator in order to simplify the prototype. • Was able to obtain a prototype which could swiftly provide a very precise value of the field’s magnitude to measure for a large array of orders of magnitude.

Semester Project: “Microfluidic System for Monitoring the Glucose level in Blood by Electrical Impedance”, Supervisors P. Renaud and L. Colella, LMIS4, EPFL Had to design, fabricate and use a microfluidic circuit in order to study the effect of specific perfusions over the blood cells. On the long term the project would help diabetic patients. Results: • A PDMS circuit was made and, with the use of a chip with interdigitated electrodes, the effect of d-glucose could be studied over the cell membrane of the erythrocytes.

Semester Project: “Flexible Electronics”, Supervisors J. Brugger and K. Sidler, LMIS1, EPFL Studied the advantage of stencil lithography as a tool to create microscopic flexible electronics. Experienced the effect of mechanical strain over the electrical parameters of these. Results: • Could characterize the change of resistivity of the flexible electronic circuits fabricated with stencil lithography and elaborate an explicative theory.

Organizer of a bar for the field trip to NASA.