Offer summary
Qualifications:
MS or PhD in Pharmaceutics, Pharmaceutical Chemistry, or Chemical Engineering, Approximately ten years of pharmaceutical industry experience, Experience with Investigational Medicinal Products (IMP), Knowledge of FDA, EU, and ICH regulations, Proficient in project management tools.
Key responsabilities:
- Manage pharmaceutical development at contract manufacturing organizations
- Collaborate with internal teams and external partners for CMC projects
- Oversee formulation and analytical development activities
- Ensure cGMP compliance through review of production records
- Approve documents for regulatory submissions such as NDA and MAA