CMC Program Manager: Global Small Molecule Development

Barrington James; San Jose (CA); On-site; USD 170,000 - 210,000; Full time

Job summary

Qualifications

• Requires degree in Life Sciences, Chemistry, Engineering or Business (advanced degree advantageous).
• 5+ years' experience in CMC development and project management in pharma/biotech.
• Experience supporting small molecule development across clinical to submission.
• Proven ability to lead cross-functional planning, execution and decision-making.

Responsibilities

• Develop and govern CMC program governance with meetings, reporting, and decision processes.
• Prepare materials, track risks/issues, and ensure escalation and follow-up.
• Build integrated project plans with milestones, dependencies, and regulatory deliverables.
• Coordinate cross-functional execution across Drug Substance, Drug Product, Manufacturing, Analytics, Quality, Regulatory, and Supply Chain.
• Track progress, identify risks, resource gaps, and timeline impacts; support mitigation.
• Create updates and reports to communicate progress and decisions to leaders.
• Support budget tracking, spend forecasting, and finance coordination.
• Collaborate with CDMOs and suppliers for timelines and commitments.
• Drive consistency in PM tools, reporting standards and processes.

Skills

Cross-functional

Project management

Communication skills

Strategic partnering

Regulatory knowledge

Education

Bachelor's in Life Sciences

Advanced degree preferred

Tools

Smartsheet

SAP

Ariba

Coupa

Job description