Principal Drug Product Specialist (On-site)

Job summary

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

Responsibilities

• Lead oral formulation development from early research into Phase 1 and Phase 2, including design of experiments and stability strategies
• Design drug product manufacturing processes and define scale-up strategies
• Execute test strategies, including dissolution and stability testing, to support formulation decisions
• Provide input to drug product manufacturing plans to ensure supply readiness
• Collaborate with contract manufacturing organizations for product and process risk assessments

Skills

• Strong communication skills and ability to collaborate across functions
• 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

• Experience with laboratory-scale experiments and troubleshooting