Job Title: Senior Formulation Manager
About the Role
* As Senior Formulation Manager, you will oversee the development and execution of complex formulation strategies within a specialty pharmaceutical company.
* You will lead teams responsible for creating innovative parenteral drug products, driving project timelines and ensuring high-quality results.
Key Responsibilities
* Develop comprehensive project plans, including risk assessments and contingency planning, in line with overall R&D goals.
* Monitor project progress, ensuring timely delivery and adherence to quality standards.
* Contribute to cross-functional initiatives, fostering collaboration and knowledge sharing across departments.
* Maintain accurate documentation, supporting regulatory submissions and inspection readiness.
* Collaborate with transfer teams and clinical development groups to ensure seamless project execution.
Requirements
* A Ph.D. in Chemistry, Chemical Engineering, or Pharmaceutical Technology, or equivalent experience (7+ years) in parenteral drug product development.
* Profound understanding of development processes and pharmaceutical sciences, including aseptic, solution, and suspension formulations.
* Strong knowledge of laboratory tools, such as Quality by Design, statistical software, and Process Analytical Technology.
* Familiarity with devices like pre-filling syringes, vials, and combination products is beneficial.
* Exceptional scientific leadership skills and ability to communicate complex ideas effectively.
* Proficiency in data analysis and visualization, including application of data science tools.
* In-depth knowledge of GLP, GMP regulations, and policies relevant to parenteral Drug Product development and manufacturing.