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CDI - Genève


  • Pays : Suisse
  • Canton : Genève
  • Salaire : Confidentiel
  • Secteur :
    • Pharmacie Parapharmacie Biotechnologie
  • Référence : SUB/DI/013530

Description du job

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

Profil recherché

- 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