Sr. Manager, CMC Project Management

Job Description

Job Description

Salary:

About Aura:

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 Sr,. Manager, 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 numerous CDMOs. As this position is forward-facing and highly visible, it requires excellent oral and written communication skills and the use of project management tools to effectively develop, manage and track project plans, timelines, actions and risks.

Responsibilities include but are not limited to:

• Manage cross-functional project CMC team or sub-teams for multiple development programs as assigned.
• Partner proactively with 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.
• Create project management templates for actions trackers, risk registers, project plans to be used cross-functionally and with external partners.
• Collate project activities, develop timelines and Gantt charts and present information as needed to team members and leadership.
• Prepare agendas, facilitate meetings, capture detailed minutes with key actions and decisions, and monitor open action items for completion.
• Ensure that each workstream is supported by a comprehensive project plan, and for those without one, develop, maintain, and formally disseminate an appropriate plan.
• Organize project information into shared areas for ease of access.
• Identify and escalate project risks to the Executive Director of CMC Project Management.
• Support management of CMC budget.

Minimum Requirements:

• Bachelors degree in pharmaceutical or biotechnology and minimum 5 years of project management experience.
• Minimum of 10 years of experience in Pharmaceutical or Biotechnology related field (large molecule experience preferred) with direct CMC, drug development and cross-functional experience.
• Strong knowledge and application of standard Project Management tools with experience in Smartsheet, MS Project, Power Point, Excel and SharePoint.
• Direct CMC experience with solid understanding of drug development lifecycle from pre-clinical to commercial.
• Ability to clearly and concisely disseminate and manage information flow across all levels of the organization.
• Ability to build strong relationships with cross-functional team members and with external CDMOs/collaborators.
• Detail-oriented with the ability to organize information in a logical and systematic way for easy retrieval and reference.
• Ability to function independently, manage priorities, meet agreed deadlines with a high tolerance of flexibility in a dynamic environment.
• Ability to 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.
• Ability and willingness to travel to CDMOs as required (10-20%).

Salary & Benefit Information:

Salary Range: $145,000/yr - $185,000/yr

(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)

Health insurance with FULL premium coverage

401K with company match

Employee Stock Purchase Program (ESPP)

Competitive paid time off (PTO)

Company-paid short & long-term disability insurance and life insurance