Lead, Small Molecule Drug Substance — Process Development

GlaxoSmithKline; Zebulon (NC); Hybrid; USD 149,325 - 248,875; Full time

Job summary

GlaxoSmithKline in the United States seeks a senior leader to drive small molecule drug substance development from lab through clinical and commercial readiness. You will guide process development, scale-up, technology transfer, and cross‑functional collaboration with CMC, analytical development, quality, regulatory, and manufacturing teams.

The role emphasizes practical scientific judgment, clear communication, and mentoring, with hybrid work in NC.

Qualifications

• 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.

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.

Skills

Cross-functional leadership

Process development

Scale-up experience

Project coordination

Communication skills

Education

Bachelor's degree in chemistry/chemical engineering/pharmaceutical sciences

Job description

GlaxoSmithKline in the United States seeks a senior leader to drive small molecule drug substance development from lab through clinical and commercial readiness. You will guide process development, scale-up, technology transfer, and cross‑functional collaboration with CMC, analytical development, quality, regulatory, and manufacturing teams.

The role emphasizes practical scientific judgment, clear communication, and mentoring, with hybrid work in NC.