Manager, CMC Project Management

About Aura Biosciences

Aura Biosciences is a clinical-stage biotechnology company developing bel-sar, a potentially transformative, first-in-class therapy for patients living with ocular cancers. Bel-sar represents an entirely novel approach to treating ocular cancers via its dual mechanisms of action of acute tumor necrosis and secondary anti-tumor immune activation. The Phase 3 registration study of Bel-sar in early choroidal melanoma, the largest patient segment of uveal melanoma, is fully enrolled, and earlier stage studies in metastases to the choroid and cancers of the ocular surface are ongoing. Aura's mission is to improve outcomes for patients living with ocular cancers by delivering a therapy that not only arrests tumor growth but also preserves vision and quality of life.

For more information, visit aurabiosciences.com. Follow us on X, @AuraBiosciences, and visit us on LinkedIn.

Position Summary:

Reporting to Associate Director, CMC Program Management, the CMC Project Manager 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.
• Serves as the day-to-day project contact for CDMOs and other external partners; track deliverables, timelines and contractual commitment, and support manufacturing campaign planning.
• Use and help improve templates for actions trackers, risk registers, and 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 Associate Director, CMC Program Management.
• Support management of CMC budget.

Minimum Requirements:

• Bachelor’s degree in pharmaceutical sciences, biotechnology, engineering, life sciences or a related field (or equivalent working experience); PMP or equivalent certification preferred but not required.
• Minimum of 5 years of experience in 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 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.
• Experience working with CDMOs (e.g., tech transfer, batch execution, process or analytical validation) preferred.
• 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.

Salary & Benefit Information:

Salary Range: $130,000/yr - $160,000/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)

Industry competetive Medical, Dental, and Vision Insurance

401K with company match

Employee Stock Purchase Program (ESPP)

Unlimited paid time off (PTO)

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