Industrial Affairs Project ManagerMichael Page

As a leading recruitment agency in the region, we're always on the lookout for top talent to help our clients achieve their business goals. If you're a professional with experience in the life sciences industry and are interested in new career opportunities, we'd love to hear from you!

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

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

PharmD or related Engineer degree with pharmaceutical / industry specialization
- About 3 years of experience working in development
- Excellent English communication skills, both in written and spoken