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Vera Therapeutics, Inc. · 23 hours ago

Associate Director, CMC Program Management

United States

Full-time

Remote

Lead/Staff, Director/Executive

$148K/yr - $226K/yr

8+ years exp

Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. The Associate Director of CMC Program Management will oversee and execute CMC commercial, lifecycle management, and preclinical activities, ensuring alignment with organizational objectives and managing project timelines.

BiotechnologyHealth Care

Responsibilities

Develop, maintain, and track project timelines and deliverables for CMC activities, ensuring alignment with organizational and departmental objectives

Coordinate commercial supply readiness and next generation process development activities across CMC, quality, regulatory, commercial, and external CDMO/CMOs

Act as a liaison between CMC team and external partners, consolidate and disseminate key decisions and updates across cross-functional workstreams

Support CMC Subteam and other governance forums to develop, track and execute on CMC functional objectives and lifecycle management initiatives

Work with CMC team to develop, manage and track the CMC budget

Provide CMC project management support, both internally and externally with vendors. This includes activities such as drug substance/drug product development, manufacturing, and supply chain oversight. Proactively track and manage activities at vendors and facilitate resolution of issues to keep project activities on track

Create and maintain program management tools to communicate timelines, deliverables, issues, risks, and mitigations. Ensure cross functional alignment on program status including expectations, opportunities, and risks

Qualification

Biotech experienceCMC program managementPMPMicrosoft ProjectBudget managementSmartsheetSelf-directedAttention to detailEffective communicationCross-functional collaboration

Required

BS/MS degree in a scientific or engineering discipline

8 years of biotech experience in any of the following sub-disciplines; process development, manufacturing, and/or analytical development

5 years of CMC program management experience

Proficient in Microsoft Project

High level of attention to detail

Ability to work with ambiguity, and create new, more efficient processes; desire to bring order and organization to a newly developing organization

Ability to communicate effectively with stakeholders across the organization at all levels

Proven ability to manage competing priorities, budgets, and timelines in a fast-paced, rapid-growth environment

Highly skilled at working collaboratively with cross-functional teams and contractors to drive results and meet company objectives

Excellent written and verbal communication skills, including a demonstrated ability to effectively communicate in a program team environment, within department, among functional groups, and external collaborators

Self-directed and proactive with ability to function independently, exercise good judgment, and respond quickly and effectively to changing environments