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Aurion Biotech · 12 hours ago

CMC Project Manager

United States

Full-time

Remote

Mid, Senior Level

$111K/yr - $136K/yr

5+ years exp

Aurion Biotech is a clinical-stage biotechnology company dedicated to restoring vision to millions of patients through innovative regenerative therapies. They are seeking a CMC Project Manager to support their CDMO and clinical trial activities, coordinating project timelines and ensuring effective execution of service agreements.

BiopharmaBiotechnologyHealth CareMedical

Responsibilities

Serve as the day-to-day liaison between internal teams and CDMO partner, coordinating project timelines, deliverables, and communications

Manage CDMO performance, ensuring adherence to service and quality agreements and effective execution of SOWs

Develop and maintain project timelines, ensuring all milestones are met according to project requirements

Schedule and facilitate project meetings, including setting agendas, preparing materials, taking accurate meeting minutes, and distributing them to relevant stakeholders

Serve as the primary point of contact for project-related communication between internal teams, external vendors, and stakeholders

Support financial tracking for CDMO projects, including creation and management of SOWs, purchase orders, and change orders to ensure alignment with project scope and timelines

Identify project risks and escalating issues as necessary to ensure timely resolution

Maintain accurate and up-to-date project documentation, including project plans, status reports, and other relevant materials

Qualification

CMC ExperienceCell Therapy KnowledgeProject ManagementRegulatory KnowledgeMicrosoft Office SuiteSharePointSmartSheetOrganizational SkillsCommunication SkillsCollaboration Skills

Required

Bachelor's degree in a related field (e.g., Project Management, Engineering, Life Sciences) or equivalent experience

5+ years of experience in a pharmaceutical or biotechnology setting with 3+ years of CMC or external manufacturing project management, direct exposure to cell or gene therapy programs

Strong organizational and time management skills, with the ability to prioritize tasks effectively

Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams

Proficiency in Microsoft Office Suite, SharePoint, and Smartsheet

Able to and comfortable with travel up to 25%

Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met

Must have strong attention to detail and demonstrated decision making ability

Ability to work individually and in a team environment

Demonstrated excellence in written and verbal communication skills

Strong collaboration and demonstrated ability to work cross-functionally at all levels of the organization to drive strong business partner relationships