Small Molecule Drug Substance Lead

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

Position Summary

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.

Responsibilities

These responsibilities include some of the following:

• 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.

Key Working Relationships

• Collaborate with CMC, analytical development, quality, regulatory affairs, clinical supply, manufacturing, and external contract organizations.
• Engage suppliers, contract manufacturers and external labs to align technical approaches and timelines.
• Present program status, risks and mitigation plans to project teams and decision forums.

Basic Qualification

• 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.

Preferred Qualification

• 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.

Working Model

• 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.

What we value in you

• You put patient impact and safety at the center of your decisions.
• You communicate clearly and make practical, evidence‑based recommendations.
• You build collaborative relationships and work with humility.
• You learn from experience and share knowledge to raise team capability.
• You demonstrate inclusive behavior and support a culture of inclusion.

Ready to apply?

If this role matches your skills and career goals, we encourage you to apply. We welcome candidates who bring scientific leadership, practical problem solving and a commitment to improving patient outcomes. We look forward to hearing from you.

#LI-GSK

Salary ranges for new hires in this position in the U.S. range from $149,325 to $248,875, based on location, experience, education, and market rates. This position also offers an annual bonus and eligibility to participate in a share‑based long‑term incentive program. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.