Director or Senior Director, CMC Program Management

Scorpion Therapeutics; United States; On-site; USD 190,000 - 280,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior CMC leader to drive end-to-end program management for mid to late-stage programs, coordinating drug substance, product, analytical development, quality, regulatory, and supply chain tasks.

You will lead Phase 3 preparations, NDA/MAA submissions, and technology transfer for commercial scale, while guiding cross-functional teams and ensuring regulatory readiness across FDA/EMA requirements.

Qualifications

• PhD or MS in pharmaceutics, pharmaceutical sciences, chemistry, or chemical engineering.
• 10+ years (PhD) or 15+ years (MS) of CMC experience; Sr. Director level adds seniority.
• CMC program management for oral small molecules through Phase 3 and regulatory submissions.
• Broad CMC knowledge across drug substance, product, and analytical development.
• Experience with CDMOs/CROs, technology transfer, GMP manufacturing, and supply management.
• Knowledge of FDA/EMA/ICH CMC regulations, GMP/GLP, and inspection readiness.
• Ability to manage complex cross-functional programs with strong communication and organization.
• Proficiency with project management tools like MS Project and Smartsheet.

Responsibilities

• Drive end-to-end CMC program management for mid to late-stage programs, including timeline development, critical path identification, risk assessment, and execution tracking.
• Build and maintain integrated plans spanning drug substance, drug product, analytical, quality, regulatory, and supply chain workstreams.
• Support Phase 3, NDA/MAA submission, process validation, and commercial-scale technology transfer.
• Conduct CMC team meetings; ensure clear, timely communication of status, risks, decisions, and issues.
• Participate in CDMO/CRO meetings to monitor status, action items, and risks; identify items requiring action.
• Coordinate preparation, review, and on-time delivery of CMC components for global regulatory filings.
• Serve as the CMC timeline and deliverables go-to contact for CMC function leads and cross-functional partners.
• Develop CMC best practices for decision-making and scenario planning.
• Promote cross-functional collaboration and execution excellence.

Skills

CMC leadership

Pharmaceutical sciences

Cross-functional leadership

Regulatory knowledge

CDMOs/CROs experience

Technology transfer

GMP knowledge

Inspection readiness

MS Project / Smartsheet

Oral small molecules focus

Education

PhD in Pharmaceutics or related field

MS in Pharmaceutical Sciences or Chemical Engineering

Tools

MS Project

Smartsheet

Job description

How you’ll make an impact:

• Drive end-to-end CMC program management for mid to late-stage programs, including timeline development, critical path identification, risk assessment, and execution tracking.
• Build and maintain integrated plans spanning drug substance, drug product, analytical, quality, regulatory, and supply chain workstreams.
• Support Phase 3, registration and validation campaigns, commercial-scale technology transfer, and commercial readiness for oral solid dosage forms.
• Conduct CMC team meetings; ensure clear, timely communication of status, risks, decisions, and issues.
• Participate in CDMO/CRO meetings to monitor status, action items, and risks; proactively identify items requiring action.
• Coordinate preparation, review, and on-time delivery of CMC components for global regulatory filings with Regulatory Affairs and subject matter experts.
• Serve as the CMC timeline and deliverables go-to contact for CMC function leads, core team program managers, and cross-functional partners.
• Develop CMC best practices for decision-making and scenario planning.
• Promote cross-functional collaboration and execution excellence.

Skills and experience you’ll bring:

• PhD/M.S. (or equivalent) in pharmaceutics, pharmaceutical sciences, chemistry, or chemical engineering; 10+ years (PhD) or 15+ years (M.S.) of CMC experience (Sr. Director: commensurate additional experience).
• CMC program/project management for oral small molecule programs through Phase 3, NDA/MAA submission, process validation, and approval.
• Broad CMC technical knowledge across drug substance, drug product, and analytical development.
• Experience with CDMOs/CROs, technology transfer, GMP manufacturing, and commercial supply management.
• Working knowledge of global CMC regulatory requirements (FDA/EMA/ICH), GMP/GLP compliance, and inspection readiness.
• Ability to manage complex cross-functional programs; exceptional communication, organization, and attention to detail.
• Proficiency with project management tools (e.g., MS Project, Smartsheet).