Laure Cahuzac
Deputy Director, Development & Process Optimization
Basel
Summary
Experienced leader with over 10 years in the pharmaceutical and biotechnology industry, specializing in business planning, project management, and CMC development. Proven track record in leading cross-functional teams, optimizing performance, and driving strategic initiatives to align with organizational goals. Adept of performance optimization, with a strong track record in facilitating communication and engagement across diverse team.
Overview
12
12
years of professional experience
2013
2013
years of post-secondary education
5
5
Languages
Work History
Global Head of Development | Basel Site Head
Bacthera AG
01.2022 - Current
- Company Overview: Bacthera is a joint venture from Lonza and Chr
- Hanssen
- Overseeing a global team of 30 collaborators across Denmark, Spain, and Switzerland, encompassing three departments: Drug Substance, Drug Product, and Analytical Development
- Oversee and ensure smooth end to end operations at our Drug Product Center of Excellence site, with key functions involved in manufacture of the product (EHS, Manufacturing, Facility & Engineering, Quality Control, Quality Assurance)
- Combined Basel and Development, 50 + collaborators (6 direct reports), for a total OPEX budget of ca
- CHF 9 millions
- Improved Development efficiency by implementing organizational framework, deploying and enhancing planning capabilities, and transition to a project-based operational model, ultimately resulting in a 30% increase in throughput
- Introduced a fast track CMC development concept, combining best practices and risk management principles to better match customer needs in term of expediting early-stage CMC development while maximizing success rates
- Oversee the adoption of cutting-edge technologies and methodologies, aligned with market demands
- Led a global corporate project aiming at transitioning from a purely functional operating model to a Site Center of Excellence / Product centric mode of organization
- The Site centric approach was successfully implemented in 2023
- Facilitate the implementation and adoption of a Tier meeting structure on a global scale to enhance communication flow
- Sponsor the deployment of a companywide capacity tool to create an integrated view of capacities, enabling alignment of demands (sales) with supply and supporting an easier project intake
- Tool development and integration in S&OP flow
- Led a restructuring project (Business case definition, HR and legal, execution and communication plan) and aiming at network consolidation
- Bacthera is a joint venture from Lonza and Chr
- Hanssen
Project Manager
Bacthera AG
01.2021 - 01.2022
- Company Overview: Bacthera is a joint venture from Lonza and Chr
- Hanssen
- Responsible for the Drug Product program, three customer projects for a budget > CHF2m: managing customer projects from RFP to completion, developing project plans tailored to customer needs, mitigating risks and issues, building and leading project teams, and mentoring team members
- Supervised the first Drug Product process transfer and established the basics and fundamentals for further Tech Transfer activities
- Managed the Analytical development / QC interface to ensure a smooth and seamless analytics transfer for various customer projects
- Led a team of expert from different discipline aiming at streamlining the cell banking workflow
- Bacthera is a joint venture from Lonza and Chr
- Hanssen
Head of Downstream process development
Ichnos Sciences
01.2019 - 01.2021
- Company Overview: Ichnos is a spin-off of Glenmark Pharmaceuticals SA
- Led a team of 7 people, managing daily operations while overseeing long-term planning, budgeting and capacity building; fostering continuous improvement and innovation to achieve long-term corporate goals
- Oversee the Operational Excellence program from 2020, addressing topics such as cost reduction, risk mitigation, process improvement and innovation
- Managed 5 project streams and over 40 collaborators in a matrix set up
- Led two Operational Excellence projects including the definition of a milestone concept for a standard CMC road map from DNA to IND, to enhance speed and success rate to FIH (2020), and the optimization of the Tech Transfer workflow by establishing governance, framework, tools and methodologies (2019)
- Support the introduction of developability assessment concept at the interface between R&D and CMC -2019/2020
- Support the introduction of QbD principles and its associated elements to support late phase CMC development activities – 2018/2019
- Led the creation of a pFMEA process for late stage development activities, as a key input to the definition of a Process Control Strategy
- – 2018/2019
- Ichnos is a spin-off of Glenmark Pharmaceuticals SA
Principal Scientist
Glenmark pharmaceuticals SA
01.2018 - 01.2019
- DSP team manager for 3 associates and 1 scientist
- Transformed the DSP laboratory into a lean and efficient organization by implementing 5S principles to improve workflow, optimize stock management, and standardize documentation
- Lead the rollout of an Electronic Lab Notebook system across DSP, and promote its wider adoption within the entire Process Sciences department
- Enable the integration and effective utilization of Statistics within the DSP
Senior Scientist
Glenmark pharmaceuticals SA
01.2016 - 01.2017
- Managed purification development for new drug candidates, overseeing operations from small scale to scale up, while also supervising process optimization, transfer, and changes both internally and with Contract Manufacturing Organizations (CMOs)
- Support the writing and successful submissions of 2 INDs
- Led the optimization of a Downstream process for a Phase IIa program, transitioning the administration route from IV to SubQ
- Supervised subsequent tech transfer operations at a US-based CMO; support comparability exercises
- Support the scale-up of a Downstream process from 200 to 2,000 L in an Indian-based CMO for a biosimilar program entering phase III
- Support the transfer and subsequent scale-up of a Downstream process from 1,000 to 5,000 L in a Korean-based CMO for a Phase IIb program; support comparability exercises
Scientist
Glenmark pharmaceuticals SA
01.2013 - 01.2016
- Development of purification processes, scale up and tech transfer to GMP for new drugs candidates
- Contribute to 2 INDs and 2 IMPDs successful submissions
- Drive the definition of Glenmark’s mAbs and BEAT BsAbs purification platforms
- Member of the team setting-up a new GMP facility; the facility was grant Swiss medic license and successfully launched in 2014
Education
MSc - Biotechnology
ENSTBB
BSc - Biology
CPBx
PMP - undefined
PMI
Skills
- Effective Team Leadership
- Effective Communication
- Stakeholder management
- Project management
- Financial acumen
- Strategic thinking
- Accountability
- Solution oriented
Residency
Swiss resident permit C
Personal Information
- Date of Birth: 02/05/90
- Nationality: French
Miscellaneous
- 01/01/24, Currently following a 6 weeks course on 'Venture Capital: Master start-up funding and investment strategies' by Imperial College Business School London
- 01/01/23, 6 weeks courses on 'Building Financial acumen for non-Financial manager' by University of Toronto - Rotman School of Management
- 01/01/22, Attend 35 hours Project Management courses delivered by Romandie formation, a training center certified by PMI
- 01/01/21, Attend the 2 days 'Process validation for Biotechnological products' on-line master class – CLC
- 01/01/20, Speaker during the Downstream expert event organized by Merck – topic of the talk 'High concentration development and manufacturability challenges'
- 01/01/20, Attend the CASSS CMC strategy forum in Washington
- 01/01/18, Attend the CMC Pharma Regulations Master Class - CLC in Vienna
- 01/01/15, 5 days advanced courses on statistics using JMP
Timeline
Global Head of Development | Basel Site Head
Bacthera AG
01.2022 - Current
Project Manager
Bacthera AG
01.2021 - 01.2022
Head of Downstream process development
Ichnos Sciences
01.2019 - 01.2021
Principal Scientist
Glenmark pharmaceuticals SA
01.2018 - 01.2019
Senior Scientist
Glenmark pharmaceuticals SA
01.2016 - 01.2017
Scientist
Glenmark pharmaceuticals SA
01.2013 - 01.2016
BSc - Biology
CPBx
PMP - undefined
PMI
MSc - Biotechnology
ENSTBB
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