Biologics CMC Project Manager | Hybrid/Remote

EPM Scientific; San Francisco (CA); Hybride; USD 160 000 - 230 000; Plein temps

Résumé du poste

EPM Scientific in San Francisco, California, seeks a CMC Project Manager (Biologics) to drive IND-enabling activities and clinical-entry readiness. You will coordinate drug substance and drug product development, analytical development, and manufacturing with international CDMOs, tracking timelines, risks, and deliverables.

You will lead cross-functional teams, manage meetings, and maintain dashboards, risk registers, and leadership updates.

Qualifications

• Bachelor's degree or higher in pharmaceutical sciences, chemistry, chemical engineering, biology, biochemistry, or a related scientific discipline.
• Approximately seven or more years of relevant experience in biotechnology, pharmaceutical development, biologics manufacturing, or CMC project management.
• Experience coordinating external CDMOs, CROs, testing laboratories, consultants, or other technical vendors.
• PMP certification or formal project-management training is helpful but not required.

Responsabilités

• Manage integrated CMC project plans across drug substance, drug product, analytical development, Quality, Regulatory, and supply activities.
• Serve as primary operational interface with international CDMOs and external development partners, tracking commitments, dependencies, and delivery timelines.
• Coordinate manufacturing readiness, testing, release, packaging, and delivery of materials supporting IND-enabling studies and clinical development.
• Track manufacturing campaigns, raw-material availability, method development and transfer, stability studies, and batch-release requirements.
• Lead project meetings, document decisions, assign actions, and maintain clear timelines, dashboards, risk registers, and leadership updates.
• Identify technical, operational, quality, and scheduling risks, partnering with subject-matter experts on mitigation and escalation.
• Support technology transfer and coordinate the exchange and review of technical documentation between internal teams and external partners.
• Coordinate CMC submission deliverables and partner with Quality and Regulatory on documentation supporting deviations, change control, comparability, specifications, and filing readiness.
• Establish practical project-management processes that support a growing organization and effective collaboration across international time zones.

Formation

Bachelor's degree or higher in pharmaceutical sciences, chemistry, chemical engineering, biology, biochemistry, or a related scientific discipline

Description du poste

EPM Scientific in San Francisco, California, seeks a CMC Project Manager (Biologics) to drive IND-enabling activities and clinical-entry readiness. You will coordinate drug substance and drug product development, analytical development, and manufacturing with international CDMOs, tracking timelines, risks, and deliverables.

You will lead cross-functional teams, manage meetings, and maintain dashboards, risk registers, and leadership updates.