Associate Principal Scientist, Preclinical Development

Merck's Sterile Product Development group seeks an Associate Principal Scientist to lead biologics formulation and process development from preclinical through commercial stages. The role involves designing experiments, characterizing drug products, managing cross-functional teams, and advancing innovation in non-oral dosage forms.

Responsibilities

• Lead experimental design, execution, and data analysis for innovative biologics sterile product development approaches
• Support early and late-stage candidates through composition screening, process development, packaging characterization, and regulatory documentation
• Provide strategic and technical leadership across program teams, interfacing with stakeholders and driving milestones
• Oversee technology transfers and external manufacturing site activities
• Champion organizational innovation objectives and advance knowledge through patents, presentations, and professional activities

Requirements

• Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related field with 3+ years industry experience
• Extensive biologics process development and characterization experience, particularly late-stage programs
• Demonstrated expertise in formulation development, manufacturing processes, and regulatory filings
• Strong verbal and written communication skills with ability to mentor diverse teams
• Track record of technical innovation reflected through publications, patents, or product development achievements
• Knowledge of formulation science, drug delivery technologies, and manufacturing scale-up