Director, CMC Project Management

Aura Biosciences•Brighton, MA

About The Position

Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients. For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn. Position Summary: Reporting to the Head of CMC Project Management, the Director CMC Project Management will be responsible for managing CMC drug development activities working cross-functionally within internal Technical Operations, Quality, Regulatory, Device and Clinical Teams and externally with key CDMOs. This role will be primarily focused on drug substance, drug product, and analytical validations, technology transfer and operations within our CDMOs. As this position is forward-facing and highly visible, it requires excellent oral and written communication skills including stakeholder management and the use of project management tools to effectively develop, manage and track project plans, timelines, actions and risks.

Requirements

Bachelor’s degree in pharmaceutical or biotechnology and minimum 8 years of project management experience leading cross-functional teams in biotechnology related field.
Minimum of 12 years of experience in Pharmaceutical or Biotechnology related field (large molecule experience preferred) with direct CMC, drug development (pre-clinical to commercial), process transfer, facility change and comparability.
Proven ability to influence senior stakeholders and clearly and concisely disseminate information within the organization.
Ability to build strong relationships with cross-functional team members and with external CDMOs/collaborators.
Highly organized, detailed oriented with strong problem solving and analytical skills.
Ability to function independently, manage priorities, meet agreed deadlines, adapt to evolving priorities and thrive in fast-paced environment.
Ability to take accountability, act with senses of urgency, drive decisions, manage conflict and steer towards a resolution.
Ability to communicate effectively and professionally, both orally and in writing, with internal and external partners.
Strong knowledge and application of standard Project Management tools with experience in Smartsheet, MS Project, Power Point, Excel and SharePoint.
Ability and willingness to travel as required (25%).

Responsibilities

Provide leadership to cross-functional teams in the oversight, design and execution of process and analytical validations, technology transfers, and operations within CDMOs.
Lead, track and maintain CMC budget for CDMOs.
Manage cross-functional project CMC sub-teams for multiple development programs.
Build and maintain strong positive working relationships with CDMOs.
Act as single point of contact and timely disseminate key information between internal CMC team, stakeholders and external CDMOs.
Partner proactively with internal SMEs and cross functional team members to understand strategy, drive decisions, outline activities, identify any risks, gaps and resources constraints to develop and maintain project plan.
Develop, organize, and maintain dashboards, timelines, project plans and present information to CMC team and stakeholders.
Identify, track and escalate project risks to senior stakeholders.
Demonstrate strategic leadership skills including the ability to influence senior stakeholders.
Prepare agendas, facilitate meetings, capture detailed minutes with key actions and decisions, and monitor open action items for completion.
Organize project information into shared areas for ease of access.