Small Molecule Drug Substance Lead in Irvine

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.

The role offers ownership, career growth, and the opportunity to impact the delivery of safe, reliable medicines.

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 to 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 ensure 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 Qualifications
• Bachelor’s degree in chemistry, chemical engineering, pharmaceutical sciences or a related field.
• Minimum five years of 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 Qualifications
• Clear written and verbal communication skills for diverse technical and business audiences.
• Advanced degree (MS or Ph D) 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.
• Equal Opportunity Employer

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.

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