Associate Director/Director, CMC Program Management

LOCATION: CAMBRIDGE, MA

About Aura:

At Aura Biosciences, we are developing a new class of therapies based on an expressed Viral Nanoparticle-Dye conjugate to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed. By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.

Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes. Come help develop a first-in-class treatment to selectively destroy cancer cells!

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Role & Responsibilities:

This position will provide technical program management of diverse CMC activities with a focus on key Intermediates (pDNA, purified protein, small molecule dye) and the final bioconjugate DS and DP. Partnering closely with the cross-functional stakeholders (Clinical, Regulatory, Product Development), you will apply strong technical and project management fundamentals to develop a CMC strategic development plan and clinical supply chain plan from phase 3 development through commercial launch.

Essential functions:

  • Reporting to the SVP Development, the Associate Director/Director, CMC Program Manager, will be responsible for developing and managing NDA deliverables for program execution with subject matter experts including process and analytical development, supply chain, and regulatory to achieve project goals on time and within budget. 
  • Develops and maintains clinical Supply Plans in close collaboration with the clinical group.
  • Facilitate strategy development and decision-making by leveraging technical and development lifecycle knowledge and seeking critical input from team leadership, SMEs, and stakeholders. 
  • Own and maintain project management tools (minutes including decisions and actions, timeline, budget, risk management, resource management) that support but do not supersede program strategy development and execution success.
  • Facilitate and manage productive team communication and collaboration, both internally and externally.
  • Communicate and publish monthly CMC dashboard to management. 

Qualifications:

  • The ideal candidate should have an advanced degree in the life sciences /engineering and 5-8 years of direct and progressive experience specific to biopharma CMC project management with a track record of successful management of complex programs using multiple external vendors. Experience with bioconjugates a plus.
  • You should have a passion for learning, creating, relating, communicating, and helping drive the success of cross functional teams.

Location:

Based in the Company’s North Cambridge office, with travel as required to oversee the virtual development and manufacturing network.

Interested? 

Email a cover letter and a copy of your CV to HR@aurabiosciences.com referencing the position description in the subject line.

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