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von: Stragen Pharma SA | localité: Plan les OuatesN: StragenPharmaSA
Accoutabilities
- 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
Skills
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
Qualifications
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
