Director, External Manufacturing

About Aura: At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed – an approach we call molecular surgery. 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 to the liver, where it almost always is fatal. Development of a first-in-class treatment option to selectively destroy cancer cells would create the possibility of a cure in this and other cancers where the disease can be detected early.

Position Summary:

Aura BioSciences is seeking a Director External Manufacturing to play a critical high-level role providing strategic oversight and end-to-end supervision of all CMO operational activities related to our early and late stage programs and set up eventual commercial operations. . This person is responsible for ensuring that CMO timelines for upstream, downstream, and custom starting materials manufacture stay on track. This person serves as the key point of contact between the Company and all vendors and consultants.

The successful candidate will have a demonstrated track record of technical and program leadership. This is an excellent opportunity for a highly motivated self-starter and creative problem solver who has a strong desire to make an important contribution to the development of novel therapies. This is a high-profile position with the opportunity to innovate in an entrepreneurial and high growth organization.

Responsibilities include but are not limited to:

  • Play a key role in advancing experimental therapeutic molecules to the clinic by providing planning, expertise and oversight on all CMO-related activities and issues
  • Proactively identify CMO risks and provide recommendations on mitigation
  • Represent CMOs at program core team meetings providing timely updates on progress and recommendations on strategy with ability to effectively communicate subject matter specific topics
  • Ensure that CMO activities remain within projected timelines and budget
  • Identify, review and select the best external CROs, CDMOs and key consultants that are needed to allow smooth, efficient and cost-effective support for programs advancing to the clinic
  • Daily collaboration with Quality, Regulatory, Supply Chain, and Development organizations
  • Responsible for negotiating, monitoring, and maintaining Agreements with Partners and CMOs, where applicable

Minimum Requirements:

  • Master’s Degree or PhD in a pertinent scientific discipline with at least 12+ years of industry experience in CMO support and vendor management
  • Proven track record of successful CMO management experience supporting early and late stage programs
  • Experience in authoring CMC sections of BLAs and previous launch experience
  • Prior experience managing or working within cross-functional project teams with timeline management and budgetary responsibility
  • Experience working with budgets both in development and managing external budgets
  • Strong knowledge of current Good Manufacturing Practices (GMP)
  • Strong knowledge of project management tools and software
  • Ability to act decisively and with urgency to solve problems
  • Strong leadership and interpersonal skills in order to influence decision-making in a diplomatic manner
  • Excellent oral and written communications with ability to present data to all levels of expert and non-expert audiences
  • Accountability and self-awareness to drive positive results
  • Strong Vendor Management skills
  • Effective organizational and planning skills
  • Flexibility to switch from strategic thinking to operational details

Interested?  Email a cover letter and a copy of your CV to referencing the position description in the subject line.