Vice President, CMC Development
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:
The VP of CMC Development will serve as strategic and scientific leader of the CMC Development function. The VP will lead and direct development projects within the functional areas of Upstream, Downstream, Formulation, Drug Product, and Analytical development to support Aura’s biologics pipeline projects. They will lead the implementation of CMC strategies for execution of Aura’s drug development programs, will represent CMC in program teams and will lead the corresponding cross-functional CMC sub-team. The role will oversee Process Development, Formulation Development, and Analytical Development functions.
Responsibilities include but are not limited to:
- Align project priorities, coordinate development activities, project deliverables and resources between CMC development functions.
- Further develop a high performing leadership team that effectively leads coordinates activities across CMC development functional areas.
- Ensure that appropriate technologies, capabilities, and capacities are identified, evaluated, and implemented on a continuing basis to ensure that Aura maintains state-of-the-art equipment and laboratory facilities to deliver on critical CMC milestones.
- Ensure seamless collaboration and efficient transfer of knowledge and technology with other functional areas of the CMC Development organization to ensure project progress according to agreed timelines.
- Establish excellence in development of virus-like drug conjugates (VDCs), building and managing the knowledge required to effectively drive the pipeline.
- Interface closely with Quality, Regulatory, Technical Operations, and Preclinical / Research in development and execution of CMC plans. Advocate and promote CMC Development positions and perspectives; collaborate, negotiate and influence to reach beneficial corporate outcomes.
- Cascade CMC decisions and communications effectively functionally and across the organization.
- Liaise with CMC Development leadership to translate CMC strategy and project plans into tactical and functional plans for the CoE.
- Oversee laboratory operations and activities across CMC development functions.
- Oversee internal PD team to ensure execution of CMC and pipeline strategy
- Oversee Process Development team that facilitates technology transfer in collaboration with the Technical Operations Team to support clinical manufacturing for bulk drug substance and drug product at contract manufacturing organizations (CMOs) and analytical testing at contract testing labs (CTLs)
- Other duties as assigned.
Minimum Requirements:
- Ph.D. in relevant scientific discipline and 15+ years’ experience in the development and manufacturing of biologics therapeutics
- Extensive experience in development of biologics process development in many different cell systems
- Demonstrated experience successfully leading CMC development activities
- Demonstrated experience successfully managing external vendors for outsourced development
- Strong ability to drive decision-making using data and influence to achieve team alignment
- Demonstrated experience establishing effective strategic plans to execute on needs of the company’s portfolio, including risk identification and mitigation, capability building, resource management, etc.
- Demonstrated experience championing a people strategy that attracts, retains, and engages employees
- Demonstrated experience with regulatory submissions, CMC technical sections of submissions and interacting with global regulatory authorities on technical matters
- Proven ability to quickly synthesize and communicate concise, logical, fact-based information and make recommendations to internal and external stakeholders
- Ability to present effectively and negotiate with internal and external stakeholders
- Able to perform in fast-paced, dynamic, constantly evolving environment.
- Excellent teamwork skills and the ability to understand and respond to the needs of multiple disciplines.
- Excellent organizational skills, time management skills and attention to de tail.
Nice to have
- Experience in writing online content
- Additional languages
- Google Adwords experience
- Strong analytical skills
THIS POSITION IS REQUIRES BEING ON-SITE