What are the responsibilities and job description for the Associate Principal Scientist, Engineering position at Merck Sharp & Dohme (MSD)?
Job Description
The Sterile Drug Product Commercialization (SDPC) group provides technical process leadership and laboratory capabilities for late-stage and commercial drug product processes.
About the Role
- Advance and commercialize intravitreal pipeline products
- Plan and execute activities associated with commercial design, characterization, and transfer of process to commercial manufacturing sites
Key Responsibilities
- Technical guidance and oversight of late-stage product and process development
- Manage DP activities through filing and Process Performance Qualification (PPQ)
- Develop robust and scalable manufacturing processes
- Drive the design and execution of process characterization activities
- Oversee lab studies to ensure 'right first time'
- Apply technical and functional knowledge to design experiments
- Influence primary packaging decisions
- Drive and influence process demonstration and qualification (PPQ) strategy
Requirements
- Bachelor of Science (B.S.) in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field
- 8 years of relevant experience
- Experience in biologics drug product fill finish process optimization, scale-up, and technology transfer of sterile products
- Knowledge of current Good Manufacturing Practices (cGMPs) and ICH Quality norms
- Experience with QbD principles and Design of Experiment (DoE)
