Job Description
Overview:
- This position is responsible for performing activities related to critical aspects of products and processes, including process development, pre-validation, and optimization of solid oral dosage forms after Abbreviated New Drug Application (ANDA) filing throughout product launch and commercial lifecycle, including process, cleaning, and packaging validation.
- Executes studies with Research and Development (R&D), Laboratory Technical Services (LTS), manufacturing, and planning.
- Maintains expertise related to formulation, raw material properties, and manufacturing processes. Identifies, analyzes, and suggests corrective actions to optimize procedures, processes, materials, technology, and regulatory compliance issues.
- Digital literacy, including basic knowledge of AI (working knowledge of Power BI, Power Platform, Python, and various presentation tools), JMP, R, etc., is necessary.
Core essential skill sets candidates must have to be considered for the role:
1. At least 1 year of experience as an MS&T Specialist
2. College fresh Master’s degree with pharmaceutical sciences or equivalent
3. Basic certifications in areas of Power Platform, AI, and Project Management, preferred