Senior Lead, Small Molecule DS & Process Development

GlaxoSmithKline; Waltham (MA); Hybrid; USD 149,325 - 248,875; Full time

Job summary

GlaxoSmithKline in the United States seeks a Senior Scientist to lead small molecule drug substance development from lab to manufacturing readiness. You will coordinate with process development, quality, regulatory and manufacturing teams to ensure robust, scalable processes and reliable supply.

The role values practical judgment, clear communication and collaborative leadership, with hybrid work in the US, opportunities for career growth and meaningful impact on patient outcomes.

Qualifications

• Minimum 10 years of industry experience in small molecule drug substance process development.
• 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 and verbal communication

Problem solving

Leadership in matrixed environment

Education

Bachelor's degree in chemistry, chemical engineering, pharmaceutical sciences, or related field

MS or PhD in chemistry, chemical engineering, or pharmaceutical sciences

Job description

GlaxoSmithKline in the United States seeks a Senior Scientist to lead small molecule drug substance development from lab to manufacturing readiness. You will coordinate with process development, quality, regulatory and manufacturing teams to ensure robust, scalable processes and reliable supply.

The role values practical judgment, clear communication and collaborative leadership, with hybrid work in the US, opportunities for career growth and meaningful impact on patient outcomes.