Industrial Affairs Project Manager

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von: Stragen Pharma SA | localité: Plan les OuatesN: StragenPharmaSA


  • Supervise the Industrial trials in accordance with regulations (ICH, EMA, FDA):

– Manufacturing process development and validation, scale-up/scale-down,

– Technology and sites transfer,

– Analytical transfers development and validation,

– DS and DP specifications establishment,

– Risk assessment reports synthesis (eg for Nitrosamines and Elemental Impurities)

– Stability studies program definition, etc.

The supervision includes at least:

– Establish the industrial strategy: development plan, budgets and timelines

– Follow the well progress of trials with the concerned partners (Active Supplier, CDMO, analytical laboratories, etc.)

– Liaise in close collaboration with internal stakeholders on a regular basis and ensure good project coordination

  • Provide technical support to Quality Assurance department for technical support (e.g. process capability, trend analysis) or in case of manufacturing or quality issues
  • Collaborate/or support with Regulatory Affairs department to elaborate the registration strategy anticipating risks and issues
  • Ensure the Product Life Cycle Management through the technical management of the post approval CMC changes
  • Conduct technical-regulatory intelligence


Personal Core Competencies

Analytical and synthesis skills

Project management

Creativity in problem solving, Pragmatic, Decision making, ready to take initiatives

Able to build and maintain good customer / supplier / manufacturer relationship

Able to collaborate with a wide range of people, team player



Pharmaceutical development and manufacturing skills

Good understanding of quality and regulatory issues (Drug substance and Drug Product)

Good knowledge of technico-regulatory guidelines (ICH, EMA, GMP)

Project management skills

Excellent English communication skills, both in written and spoken



PharmD or related Engineer degree with pharmaceutical / industry specialization

About 3 years of experience working in development within a pharmaceutical company or in management of CMC projects with external CDMOs



9 month fixed-term contract