Principal Drug Product Specialist

Job summary

The role involves leading oral formulation development for small molecules and potentially peptide-based candidates from early research through Phase 2 clinical trials. The specialist will design formulations, define testing strategies, and ensure appropriate control measures for toxicology and clinical supplies.

Qualifications

• MSc/PhD in chemistry, biochemistry, pharmaceutical sciences, or a related field
• Minimum 8 years of experience in oral formulation development of small molecules, through Phase 2
• Experience with Good Manufacturing Practice (GMP) and regulatory aspects of Chemistry, Manufacturing and Controls (CMC)

Responsibilities

• Lead oral formulation development, including design of experiments, excipient compatibility assessments, and stability strategies
• Design drug product manufacturing processes and define scale-up strategies
• Execute test strategies for dissolution, physicochemical characterization, and stability testing
• Provide input to drug product manufacturing plans for clinical supply readiness
• Conduct product and process risk assessments with contract manufacturing organizations (CMOs)

Skills

• Strong collaborative and communication skills
• Ability to balance speed with quality in early development
• Knowledge of animal models for oral bioavailability testing

Education

• MSc/PhD in relevant scientific fields

Tools

• Familiarity with laboratory equipment for formulation testing and manufacturing processes