Lead, Small Molecule Drug Substance

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

Benefits offered by this job

Health insurance

Retirement benefits

Paid holidays

Paid vacation

Parental/caregiver leave

Medical leave

Job summary

GlaxoSmithKline seeks an experienced leader to drive small molecule drug substance development from lab through manufacturing readiness. You will coordinate with process development, quality, regulatory, and manufacturing teams to ensure robust, scalable processes that meet regulatory expectations.

The role emphasizes collaboration, practical scientific judgment, and leadership skills to deliver safe, reliable medicines with clear governance and development plans.

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

Clear written & verbal communication

Project management

Education

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

Advanced degree (MS or PhD) in chemistry, chemical engineering, or pharmaceutical sciences

Job description

GlaxoSmithKline seeks an experienced leader to drive small molecule drug substance development from lab through manufacturing readiness. You will coordinate with process development, quality, regulatory, and manufacturing teams to ensure robust, scalable processes that meet regulatory expectations.

The role emphasizes collaboration, practical scientific judgment, and leadership skills to deliver safe, reliable medicines with clear governance and development plans.