CMC Strategy Director, Early Development

Women In Bio; Collegeville (PA); Hybrid; USD 180,000 - 250,000; Full time

Job summary

GSK is seeking a senior CMC leader in the United States to drive early to late-stage development of clinical products, coordinating across DS, DP, analytical, manufacturing, supply chain, quality and CMC regulatory teams. You will ensure regulatory readiness and Phase 3 support, with matrix leadership across multiple sites and partners.

You will engage with Early Development leadership, contribute to portfolio strategy with Research Units, ViiV and Global Health, and guide regulatory filings

Qualifications

• Advanced degree in chemistry, pharmaceutical sciences, chemical engineering or related field.
• 7+ years in CMC/pharmaceutical development across substances and products.
• Experience leading cross-functional, matrix-based teams in pharma/biotech.
• Knowledge of preclinical/Phase 1 roadmaps and Phase 2/3 planning.
• Experience with tech transfer, process scale-up, external manufacturing.
• Experience contributing to regulatory submissions (CMC sections).
• Strong communication and decision-making skills.

Responsibilities

• Lead CMC strategy from early development through Phase 2 and late-stage planning.
• Transition projects from discovery into Phase 1 development and manufacture.
• Define integrated CMC development plans with risk mitigations and governance.
• Deliver CMC plans via matrix team; monitor scope, cost, and timelines.
• Secure SME inputs and cross-functional reviews; manage team performance.
• Provide voice of the product to EDL/EDT and Research organizations.
• Prepare technical input for regulatory filings and health agency discussions.
• Support Phase 3 process development and supply chain design.
• Lead collaboration interfaces and governance as needed.

Skills

CMC strategy

Matrix leadership

Regulatory readiness

Cross-functional leadership

Strategic input

Technical writing

Problem solving

Education

PhD or equivalent in chemistry or pharmaceutical sciences

Job description

GSK is seeking a senior CMC leader in the United States to drive early to late-stage development of clinical products, coordinating across DS, DP, analytical, manufacturing, supply chain, quality and CMC regulatory teams. You will ensure regulatory readiness and Phase 3 support, with matrix leadership across multiple sites and partners.

You will engage with Early Development leadership, contribute to portfolio strategy with Research Units, ViiV and Global Health, and guide regulatory filings