Emmanuelle Brun Email & Phone Number

Orléans, Fr

Ville De Paris, Île-De-France, France

Orléans, Centre-Val De Loire, France

General Manager of a Contract Development and manufacturing site (45 people) and Member of Group Synerlab Executive Commitee.Scope: formulation and process development, analytical development, manufacturing, control and supply of clinical and commercial batches, quality assurance, engineering and security, business development and projets.• Define strategic orientations, manage budgets, investments and P&L.• Manage innovation: development of drug candidates including supply of clinical studies (approx. 20 active projects/year)• Team development, relationship with the CSE• Negotiate and contract: master service agreement, quality technical agreement• Qualified Person (Pharmacien Responsable) - Manufacturing and Importation/Human and Veterinary/Medicinal and Investigational products/Solid and liquid forms.=>Sales growth (+48 %)=>Developpement of new drugs (solid and liquid oral forms; NCEs, generic products; combo products…) =>Obtaining research tax credit certification (CIR); obtaining subsidies (BPI and Centre-Val-de-Loire region) for a collaborative strategic innovation project => Contribution to IDD-Tech Orléans site buyout process and its integration into Synerlab Group

Orléans, Centre-Val De Loire, France

Headed-up the re-industrialization of a CDMO site and developed an agile organization with a new customer-centric culture.Created the Quality Management System, opening up authorizations granted by ANSM/ANMV.• Led a team of 20 people (department heads, project leaders, technicians)• Areas: formulation and process development, analytical development, manufacturing and control of clinical and commercial batches (niche product), supply chain, quality assurance, engineering and security, business development and projects• Implemented operating budget and defined strategic orientations for growth • Managed drug development projects, established pricing policy, negociated with customers and suppliers• Comex Member• Qualified Person (Pharmacien Délégué) - Manufacturing and Importation/Human and Veterinary/Medicinal and Investigational products /Solid forms

Orléans, France And Basel, Switzerland

Sucessful worldwide technical development, registration and launch of 2 new innovative oral oncology drugs (TASIGNA and EXJADE).Led pharmaceutical development programs with strong strategic focus and quality awareness (including product design, API/drug product development, clinical batches manufacturing and control, transfer to production site, CMC regulatory and Life Cycle management activities).• Represent Technical R&D within international cross-functional project teams (marketing, clinical development, pharmacokinetic, regulatory) • Lead multidisciplinary teams of 7-10 scientists (F, US, CH, JP) • Accountable for budget (5-8 M$) and resources planning and allocation• Critical review and approval of CTD Modules 3, replies to Health Authorities (EMEA, FDA, PMDA…)• Preparation and participation in FDA’s Pre-Approval Inspections (PAI) Acted as an active member of Global Technical Project Management Team: • Peer reviews, lessons learned working groups • Training and coaching of scientists and departmental project leaders• Participated in product due-diligence to support in-licensing process

Orléans, France And Basel, Switzerland

Led analytical development and elaborated control strategies for drugs. • Project management of drug candidates (3-5 projects/year; NCEs; solid forms)- Led a team of 10 lab technicians (recruiting, performance appraisal, training, planning, supervision and technical support)- Managed technical documentation: specifications, method development, validation, tranfer and stability- Reviewed IMPD/IND, CTD Module 3 writing, replies to CMC questions (EMEA, FDA)• Contributed to the creation of a new « early phase laboratory »• Quality (GMP): LIMS implementation, local and international SOPs, equipment qualification, audits, analytical batch record review for materials and products

Grenoble, Auvergne-Rhône-Alpes, France

• Performed various analysis for API/drug product quality control and stability studies• Analytical methods development, validation and transfer (HPLC, GC, dissolution, UV, etc.)• Contributed to the implementation of the Quality System (BPF)

Post Graduate Degree (Dess) In Quality Control, Analytical Chemistry

Pharm.D. - Industry Option