Tasks

- Pharmaceutical development and manufacturing of drug products for clinical and commercial supplies
- Oversee, manage and drive the outsourced pharmaceutical development studies
- Interact as CMC team member with CMC leader and peers to coordinate project related activities and data evaluation,
- Lead CMC project teams as assigned
- Collaborate with multifunctional teams within the company and externally with partners
- Select appropriate formulations and formulation technologies based on target product profile and biopharmaceutical properties, give scientific input
- Select appropriate pharmaceutical development and manufacturing organizations
- Implement contracts and technical agreements with external pharmaceutical manufacturers and coordination of the studies to align with in-house activities
- Review and contribute to protocols for development, scale up manufacture, process validation in view of requirements for registration
- Compile, review and contribute to reports and evaluate data provided by the CMO
- Prepare progress reports and share with project team and functional management.
- Prepare registration documentation

Qualifications

- University degree in Pharmacy, and preferably with PhD degree, or equivalent education
- At least 5 years of experience in pharmaceutical development and manufacturing of drug products with focus on parenteral drugs and/or oral drug products
- Experience with requirements for registration
- Knowledge of GMP requirements
- Experience with aseptic manufacturing (would be considered an upside)
- Knowledge of MS office