Manager, CMC Project Management

Aura Biosciences • Brighton, MA

1d

About The Position

Aura Biosciences is a clinical-stage biotechnology company developing bel-sar, a potential first-in-class therapy for ocular cancers. The CMC Project Manager manages CMC drug-development activities across internal Technical Operations, Quality, Regulatory, Device, and Clinical teams, as well as external CDMOs and other partners. Reporting to the Associate Director, CMC Program Management, this highly visible role uses project-management tools and strong communication to develop, manage, and track project plans, timelines, actions, and risks. The position also supports CMC budget management and requires willingness to travel to CDMOs as needed.

Requirements

• Bachelor’s degree in pharmaceutical sciences, biotechnology, engineering, life sciences, or a related field, or equivalent working experience.
• At least 5 years of experience in a pharmaceutical or biotechnology-related field, including at least 3 years of project-management experience with direct CMC, drug-development, and cross-functional experience.
• Strong knowledge and application of standard project-management tools.
• Experience with Smartsheet, MS Project, PowerPoint, Excel, and SharePoint.
• Direct CMC experience and a solid understanding of the drug-development lifecycle from preclinical through commercial stages.
• Ability to clearly and concisely disseminate and manage information across all organizational levels.
• Ability to build strong relationships with cross-functional team members and external CDMOs or collaborators.
• Detail-oriented, with the ability to organize information logically and systematically for easy retrieval and reference.
• Ability to work independently, manage priorities, meet agreed deadlines, and adapt in a dynamic environment.
• Ability to drive decisions, manage conflict, and guide discussions toward resolution.
• Effective and professional oral and written communication with internal and external partners.
• Ability and willingness to travel to CDMOs as required.

Nice To Haves

• PMP or equivalent certification.
• Experience working with CDMOs, such as in technology transfer, batch execution, or process or analytical validation.

Responsibilities

• Manage cross-functional CMC project teams or sub-teams for multiple development programs.
• Partner with subject-matter experts and cross-functional team members to understand strategy, drive decisions, outline activities, identify risks, gaps, and resource constraints, and develop and maintain project plans.
• Serve as the day-to-day project contact for CDMOs and other external partners; track deliverables, timelines, and contractual commitments; and support manufacturing campaign planning.
• Use and help improve templates for action trackers, risk registers, and project plans for use with internal teams and external partners.
• Consolidate project activities, develop timelines and Gantt charts, and present information to team members and leadership as needed.
• Prepare agendas, facilitate meetings, capture detailed minutes with key actions and decisions, and monitor open action items through completion.
• Ensure each workstream has a comprehensive project plan; develop, maintain, and formally distribute an appropriate plan where one is not available.
• Organize project information in shared areas for easy access.
• Identify and escalate project risks to the Associate Director, CMC Program Management.
• Support management of the CMC budget.

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Employee Stock Purchase Program (ESPP)
• Unlimited paid time off (PTO)
• Company-paid short- and long-term disability insurance
• Company-paid life insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Manager