Isabelle Lacan

Erytech Inc., Cambridge, MA, USA. Program Manager • Manage cross-functional teams including Non-clinical, Clinical and CMC to prepare sections for BLA and MAA. • Support completion of various activities in diverse areas (Global Supply Chain, Sterility, Stability, Manufacturing, Extractable and Leachable, Shipping) to ensure completeness of information for filing. • Actively participate in all PMO activities including portfolio and budget creation, project reporting, resource monitoring.

• Responsible for the communication with internal and external customer. • Successfully manage multidisciplinary project teams (including Quality Control, Quality Assurance, Engineering, Validation, Analytical Development, Supply Chain) in view on delivering project as per customer needs and within pre-determined timeline and budget. • Develop and execute project plans in accordance with company policies, cGMP regulations and quality procedures. • Leads projects targeting to produce materials to be used for toxicological studies up to commercial. • Closely monitor timelines, budgets and resources based on proposed contract. • Successfully transfer processes from laboratory scale to manufacture. • Leads Root Cause Analysis and Troubleshooting as needed. • Support Continuous Improvements Actions throughout the company to improve efficiency and processes and reduce costs.

•Direct team of PD chemists transfering, designing, scaling-up and/or optimizing oligonucleotides processes. •Prepare supporting documents for manufacture ranging from toxicology to Phase III and validation. •Work closely with manufacturing, quality and engineering to continuously support the business and identify areas for improvements. •Communicate with customer directly or via project team to handle technical requests. •Participate in resource and equipment planning to ensure optimum effectiveness. •Develop and motivate PD team members to achieve personal and company objectives.

•Development and execution of various oligonucleotide processes from synthesis steps through final product. •Transfer, scale-up and support of processes to manufacture. •Use of Design of Experiment methodology to study reaction variables and optimize the process. •Assist in customer meeting. •Appointed Chemist in Charge of Process Development labs. •Involved in laboratory safety and training of co-workers.