CMC Project Manager (Biologics)

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

CMC Project Manager (Biologics) (PR/614159) San Francisco, California

Salary: USD160000 - USD230000 per year

CMC Project Manager, Biologics

• Location: San Francisco Bay Area preferred; highly relevant West Coast-based remote candidates considered
• Work Arrangement: Approximately three days onsite per week for local candidates

About the Opportunity:

We're partnering with a biotechnology company advancing a pipeline of antibody-based therapeutics to identify a hands-on CMC Project Manager.

This individual will coordinate a lead development program through IND-enabling activities and preparation for clinical entry. The immediate priority is managing the timelines, dependencies, and deliverables required to manufacture and supply drug substance and drug product through an international CDMO partner.

Working across internal technical functions, consultants, and external partners, this person will bring structure and accountability to a lean organization. The role requires someone comfortable staying close to technical details, anticipating risks, and keeping day-to-day execution moving.

Responsibilities:

• Manage integrated CMC project plans across drug substance, drug product, analytical development, Quality, Regulatory, and supply activities.
• Serve as a 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 accountable 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.

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.
• Demonstrated experience coordinating biologics CMC activities through IND-enabling development, IND preparation, clinical-entry readiness, or early clinical manufacturing.
• Working knowledge of biologics drug substance and drug product development, analytical development, formulation, stability, Quality, and supply activities.
• Experience coordinating external CDMOs, CROs, testing laboratories, consultants, or other technical vendors.
• Prior involvement in manufacturing campaigns, technology transfer, GMP documentation, batch release, or regulatory submission preparation.
• Strong project-management skills, including integrated planning, dependency management, risk tracking, meeting leadership, and cross-functional follow-through.
• Ability to understand technical information, communicate clearly, and keep stakeholders focused on deliverables and decisions.
• Comfortable operating independently in a lean environment and collaborating with globally distributed partners.
• PMP certification or formal project-management training is helpful but not required.

Bay Area candidates available onsite approximately three days per week are preferred. Highly relevant West Coast-based remote candidates with strong biologics CMC and external manufacturing experience will also be considered.

Compensation

The anticipated base salary range is $160,000-$230,000, depending on experience, level, location, and alignment with the position.