About Aura:

Aura Biosciences is a clinical stage oncology company. We are developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively, while activating the immune system to create long lasting anti-tumor immunity.

We have a goal of developing this technology in multiple cancer indications, focusing initially on two therapeutic areas – ocular oncology and bladder cancer – with a goal to expand into other areas of solid tumor oncology. Initially we have focused our clinical development in the medical field of ocular oncology, a group of rare diseases that have no drugs approved. We are in Phase 3 with our lead VDC AU-011 in choroidal melanoma.  We are also in development in non-muscle invasive and muscle invasive bladder cancer, currently in a Phase 1 trial. 

We have commenced a global Phase 3 program investigating the delivery of AU-011 for the treatment of small choroidal melanoma and indeterminate lesions.  AU-011 has to date demonstrated an excellent efficacy and safety profile in Phase 2 for choroidal melanoma, and enrolment is ongoing in the pivotal Phase 3 trial.

Position Summary:

Reporting to the Chief Technical Officer, the ED/VP of Process & Formulation Development is responsible for strategic leadership and oversight of all PD/Formulation activities, and act as the subject matter expert for technology transfer, process improvements and manufacturing support internally and externally.  As the subject matter expert, this individual will provide technical expertise in support of overall drug development programs as they advance from early to late stages of development to commercial launch. The incumbent will also oversee Lab Operations activities at 80 Guest St, taking ownership of Lab Infrastructure, safety and required permitting (IBC/BHPC Biosafety Permit, BFD Permits etc) as well as Lab Utilization and improvement planning. Additionally, the incumbent will be part of and provide strategic direction to the cross functional CMC workstreams across all stages of drug development.  This position is highly visible across the organization and is extremely critical to scaling the business.

Responsibilities include but are not limited to:

• Strategic oversight of process and formulation development and Lab Ops teams, including technical oversight, professional development, and hiring qualified personnel.
• Partner with the External Manufacturing teams to provide scientific leadership to process development and process characterization activities at external CDMOs.
• Support external manufacturing in late stage development activities to enable scaleup and PPQ
• Support the CMC team in partnership with external CDMO partners, internal clinical, quality and regulatory teams in the planning of development activities and generation of reports and documentation to support regulatory filing strategy.
• Author and review relevant sections of regulatory filings.
• Collaborate with other departments, ensure clear and timely communication and coordination of activities, work closely with and provide updates to all relevant cross-functional team members, line management and executive leadership.
• Maintain proficiency in the latest regulatory and industry initiatives, process technologies as well as emerging development strategies.

Knowledge, Skill and Abilities Requirements:

• Must have demonstrated scientific and process development expertise, late stage process requirements, process validation, and BLA requirements.
• Polished leadership, people skills and influencing skills with excellent communication and organizational abilities.
• Exceptional writing skills coupled with experience in preparing and presenting key information to stakeholders and management.
• Must be both strategic and tactical, highly motivated with a strong work ethic and attention to detail.
• Ability to function independently and work with cross-functional teams in a highly dynamic and fast paced environment where priorities can shift rapidly.
• Strong problem solving and analytical skills to understand and interpret scientific, recognize key issues and establish problem solving pathways and priorities.
• Proven people management skills with demonstrated success in managing broad teams in a matrix environment
• Experience with VLP and combination products is a plus.

Minimum Requirements:

• Ph.D. degree in a relevant scientific discipline, or M.S. and commensurate experience
• 15+ years of experience in the biotech or pharmaceutical industry with an emphasis on process development in mammalian cell culture for therapeutics/vaccines, etc.
• Demonstrated expertise in formulation, upstream and/or downstream process development and optimization for recombinant protein or viral vector production and purification
• Direct experience in early and late stage process development including process characterization
• Experience in overseeing and maintaining lab operations
• 5%-10% travel to CDMO, vendor, etc. expected

This position requires 5 days/week on site

Salary & Benefit Information

Salary Range: $230,000/yr – $320,000/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