Note: The job is a remote job and is open to candidates in USA. 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.
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
Skills
• 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
• Knowledge of regulatory requirements related to pharmaceutical or biotechnology projects
Benefits
• Full health insurance to employees and their families
• 401(k) matching
• EAP
• FSA
• Generous PTO
• Paid parking
• Subsidized commuter passes
• In-office catered lunches
• Team events
• Community projects
Company Overview
• Aurion Biotech is a clinical stage biotech company, developing a transformational platform of advanced therapies to cure blindness. It was founded in 2021, and is headquartered in Seattle, Washington, USA, with a workforce of 51-200 employees. Its website is https://aurionbiotech.com.
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