Small Molecule Drug Substance Lead

GSK

1d•Hybrid

About The Position

You will lead small molecule drug substance activities from lab development through clinical and commercial manufacturing readiness. You will work closely with teams in process development, quality, regulatory, manufacturing and supply. We value practical scientific judgment, clear communication, and collaborative leadership. This role offers visible ownership, career growth, and the chance to make a meaningful impact by helping deliver safe, reliable medicines. Join us to unite science, technology and talent to get ahead of disease together.

Requirements

Bachelor’s degree in chemistry, chemical engineering, pharmaceutical sciences, or related field.
Minimum 5 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.

Nice To Haves

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

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.
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.