Small Molecule Drug Substance Lead

About the role

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Responsibilities

• Lead the drug substance workstream for small molecule programs, guiding process development, scale-up, and technology transfer.
• Build and maintain integrated development plans, milestones and decision points that support program timelines and regulatory expectations.
• Design and execute experiments for process characterization, robustness studies, and scale-up risk mitigation.
• Cook up and coordinate cross-functional teams and external partners to resolve technical issues and secure clinical and commercial supply readiness.
• Prepare clear technical summaries, risk assessments, and recommendations for project leadership and governance.
• Mentor colleagues, share practical knowledge, and promote inclusive ways of working.

Requirements

• Bachelor's degree in chemistry, chemical engineering, pharmaceutical sciences, or related field.
• Minimum 10 years industry experience in small molecule drug substance process development, scale-up, or CMC roles.
• Practical experience in technology transfer to manufacturing sites or CMOs.
• Knowledge of process design, process characterization concepts and control strategy development.
• Proven ability to lead cross-functional workstreams in a matrixed environment.

Qualifications

• Advanced degree (MS or PhD) in chemistry, chemical engineering, or pharmaceutical sciences (preferred).
• Experience in late-stage development, regulatory submissions or supporting regulatory interactions (preferred).
• Experience with high-potency compounds, specialized handling, or complex purification processes (preferred).
• Formal project management training or experience managing multi-site transfers (preferred).
• Track record of mentoring or leading small technical teams (preferred).
• Familiarity with quality systems, risk management, and data integrity principles (preferred).

Skills

• Clear written and verbal communication skills for diverse technical and business audiences.
• Collaborative leadership.
• Practical scientific judgment.
• Inclusive behavior.

Benefits

Join us to unite science, technology and talent to get ahead of disease together.

Pay

The annual base salary for new hires in this position ranges $149,325 to $248,875.

Schedule

This role is hybrid in the United States. Expect regular on-site work combined with focused remote time. On-site presence is required for lab, manufacturing or key team activities.