Senior CMC Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the planning and execution of CMC development at both program and portfolio levels for various small-molecule assets, from initial toxicology supplies through scale-up for drug substance and drug product.

• Develop and manage comprehensive CMC project plans and risk registers.

• Define and monitor development strategies, timelines, and deliverables in collaboration with internal and external teams.

• Act as the primary day-to-day point of contact for external CDMOs in China, the EU, and the US.

• Oversee the planning, manufacturing campaign, batch execution timelines, and documentation deliverables for CROs and CDMOs.

• Organize and lead recurring meetings with cross-functional teams and CDMOs, including setting agendas, recording minutes, tracking action items, and documenting decisions.

• Communicate project status, risks, and mitigation strategies to both internal teams and external partners.

• Manage the pipeline for CMC proposals, purchase orders, and change orders.

• Maintain a multi-year rolling forecast for the CMC budget and a historical spending model, overseeing commitments, accruals, and variance analysis.

• Operate and enhance a controlled, multi-stage CMC document review process.

• Identify opportunities to expedite timelines, streamline execution, and foresee resource requirements.

⛳️ Requirements

• B.S., M.S., or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field; M.S. or Ph.D. is preferred.

• PMP certification is advantageous.

• A minimum of 5 years of CMC project management experience in the biotech or pharmaceutical industry.

• Hands-on experience in small-molecule drug substance and drug product development from IND-enabling stages through early clinical phases; experience in late-stage development is a plus.

• Knowledge of small-molecule drug development processes, including analytical method development, process chemistry, formulation, and regulatory documentation.

• Experience in managing external CROs and CDMOs across various geographical locations, including planning, communication, quality control of deliverables, and issue resolution.

• Proven ability to lead cross-functional initiatives, prioritize tasks, and manage timelines and budgets in a fast-paced, resource-constrained environment.

• Demonstrated capability to design and implement structured document workflows, approval processes, and standards within a GxP and submission-relevant context.

• Experience or a strong interest in leveraging AI and automation within operational workflows, focusing on safety, transparency, and human oversight.

• Strong technical and operational proficiency with tools such as Smartsheet, Box, Domo, Slack, and Zoom; comfortable creating or managing custom applications and integrations.

• Excellent verbal and written communication abilities.

• Proactive, results-oriented, team-focused mindset suited for a fast-paced start-up environment, demonstrating flexibility, adaptability, resourcefulness, and exceptional organizational, interpersonal, and problem-solving skills.

🏝️ Benefits

• Medical, dental, and vision coverage at 90%.

• 401(k) plan with company matching.

• Flexible paid time off (PTO).

• Company-wide weeklong recharge break.

• Adoption assistance.