Manager, CMC Project Management

Aura Biosciences•Boston, MA

2d•$130,000 - $160,000

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. The position is highly visible and requires strong oral and written communication skills and effective use of project management tools to develop, manage, and track project plans, timelines, actions, and risks. The role manages CMC project teams and workstreams across multiple development programs, coordinates with subject-matter experts and cross-functional partners, and serves as the day-to-day project contact for CDMOs and other external partners. It also supports manufacturing campaign planning and CMC budget management, and ensures project information, plans, decisions, risks, and deliverables are organized, communicated, and tracked.

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 to commercial.
Ability to clearly and concisely disseminate and manage information flow across all levels of an organization.
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 steer discussions toward resolution.
Ability to communicate effectively and professionally, orally and in writing, 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 cross-functional teams and external partners.
Collate 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 disseminate plans for workstreams that lack one.
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.