Cynthia Athlan

Develop and implement the drug product operations strategy with regards to quality, cost and timing considering internal and external resources.This includes partner selection for development and production, monitoring of contractors,financial and contractual negotiations with contractors.
Plan, organize and administer the different aspects of the technical activities required for the development and efficient scale-up of a research drug to a trial drug and then to a marketed product.
Lead the technical project teams, and coordinate with other functions (quality management, technical operations, technical regulatory affairs, preclinical development, research chemistry) depending on project status

Secteur : Pharmacie et santé

Preparing CMC documentation for CTA’s, IND’s and Marketing applications for worldwide submission of new developed drug products, as well relevant sections of Investigator brochures and Briefing Books, providing regulatory support to project teams for CMC related points.
Preparing documentation for CMC variations, manufacturing site transfers for marketed products.
Compiling and submitting product license applications (CMC part), as well variations to existing licences, preparing and compiling responses to Health Authorities questions.
Liaising with Novartis affiliates, Novartis other line functions and external companies for CMC regulatory issues: change control, regulatory compliance, questions from Health Authorities, licence renewals.

Secteur : Pharmacie et santé

Managing a team of 10 people (incl. 3 pharmacists)
Development of generics and new chemical entities, incl. scaling up and validation,
manufacturing of clinical trial material (CTM), and implementation of a Quality Assurance System for CTM,
Editing and reviewing technical part of regulatory submissions (parts IIA and IIB) as well as answers to questions from Heath Authorities,
Planning of a GMP pilot plant
Editing and supervision of SOP‘s,
Technical assistance to the production department

Secteur : Pharmacie et santé

Development of pharmaceutical products (generics: solids and liquids dosage forms), up to the production scale, redaction of production documentation, validation of methods of manufacture,
Manufacturing of clinical trial material
Support to production for technical issues and some QA activities

Secteur : Pharmacie et santé

Development of solid forms up to transfer to production
Training of technicians in R&D and Quality Control departments
QA activities: Editing SOP‘s and Site Master File
Editing manufacturing methods, short term replacements in production

Secteur : Pharmacie et santé