We are currently seeking for one of our clients, an independant pharmaceutical company based in Geneva, a Pharmaceutical Development Project Manager who will be responsible for the Chemistry, Manufacturing and Control (CMC) activities and life-cycle maintenance of the company products.
Main tasks :
- Manage Product pharmaceutical development strategy for assigned projects/products
o Establish Development Plan, Development Budget and Development Timeline ; o Screen and lead technical assessment of CMC partners (CDMOs, CROs, Laboratories, etc).
- Manage product pharmaceutical development :
o Supervise the Drug Substance manufacturer on the development, manufacturing, analytical, stability and validations activities ; o Supervise the Drug Product manufacturer on formulation development (including container/closure system), manufacture of investigationale products ; manufacturing process development and scale-up ; analytical methods development and then the whole validations.
- Write CMC (IMPD/IND) documentation and ensure Life Cycle Management according to current guidelines - Provide answers to technical questions from Health Agencies in duly time and in compliance with current regulations - Take part in regular team and technical meetings - Provide technical support in case of manufacturing or quality issues, closely link to Quality Assurance and Regulatory Affairs departments - Work in close collaboration with Supply Chain, Quality Assurance, Legal, Regulatory Affairs, company Services, etc - Develop and maintain project management skills and technical knowledge - Perform all other duties as assigned by the Department Manager/the Management
- PharmD., PhD or related scientific university degree with pharmaceutical specialization - About 5 years of experience working in development, tech transfer or production within a pharmaceutical company - Development, formulation and manufacturing skills - Pharmaceutical and manufacturing knowledge of parenteral and oral drugs with particular experience in multiparticulate and modified release systems - Understanding of quality and regulatory issues (Drug substance and Drug Product) - Ability to keep informed about technico-regulatory guidelines (ICH, Europe, America) - English communication skills, both in written and spoken - Adept in using MS Office tools (Excel, Word, PowerPoint, etc.) - Experience with a document submission management system (Docubridge…) as an asset - Ability to travel (about 20%) (driven licence recommended)
Soft skills : - Able to build and maintain good customer / supplier / manufacturer relationship - Technical proficiency & scientific creativity - Ability to synthesize technical and scientific processes and data - Focused on quality and continuous improvement - Decision making / ability to take initiatives / problem solving skills / pragmatism - Team Player - Ability to interact with a wide range of people, including colleagues, Management and external partners - Diplomacy - Flexible - Ability to plan, meet deadlines and operate within budget - Ability to juggle various projects - Ability to work under pressure