Director/Senior Director, Process Development

Company Background

At Aura Biosciences, we are developing a new class of oncology therapies, virus-like drug conjugates, or VDCs, which utilize a novel tumor targeting technology based on virus like particles, or VLPs, that selectively bind to and destroy cancer cells while activating the immune system toward tumor neoantigens released during the acute cellular necrosis.

Our lead VDC product candidate belzupacap sarotalocan (AU-011) is currently being developed for the first-line treatment of choroidal melanoma, a rare and life-threatening ocular cancer. Our goal is to treat small, early stage choroidal melanoma, while preserving patients’ vision, before the disease progresses and metastasizes to the liver, where it is almost always fatal. AU-011 is currently being evaluated in two clinical studies using intravitreal and suprachoroidal routes of administration, respectively. The data to date has demonstrated preliminary efficacy with demonstration of tumor control and vision preservation and a favorable safety profile. If approved, AU-011 has the potential to transform the treatment paradigm for early stage choroidal melanoma, where existing treatment options consist only of radioactive treatments which are associated with numerous comorbidities, including severe vision loss, secondary surgical interventions (such as cataract and glaucoma surgery) and enucleation (removal of the eye).

Beyond choroidal melanoma, Aura is also developing belzupacap sarotalacan (AU-011) for the treatment of choroidal metastasis. The choroid is the most common ocular site for metastatic disease, owing to abundant vascular supply. The primary cancers that most commonly lead to choroidal metastases include breast cancer (40-47%) and lung cancer (21-29%). Choroidal metastasis can be treated in a similar manner to choroidal melanoma. Beyond ocular cancers, Aura is advancing our VDC technology to Include The Treatment Of Patients With Non-Muscle Invasive Bladder Cancer (NMIBC).

ROLE: Senior Director / Director, Process Development

Reporting to the Head of CMC Development, the Director of Process Development is responsible for leading and oversight of all process development activities within the CMC organization at Aura Biosciences. This individual will serve as a subject matter expert within process development and provide technical expertise in support of drug development programs as they advance to and through the clinic. The incumbent will manage process development activities across all stages of drug development, making significant contributions to project teams.

Key Responsibilities

  • Manage the process development team, including technical oversight, professional development, and hiring qualified personnel.
  • Manage Upstream and Downstream process development activities across all stages of drug development.
  • Partners with the CMC team and oversees process development activities at external CROs and CMOs.
  • Review and approve protocols, batch records, reports, and manufacturing investigations.
  • Collaborate with CMO/CRO partners and with internal clinical, quality and regulatory teams; write technical reports and documents in support of regulatory filings.
  • Author and technical review process development and transfer documents ensuring good quality guidelines are adhered to throughout.
  • Author and review relevant sections of regulatory filings.
  • Give technical guidance and training to other laboratory staff as required.
  • Communicate, work closely with and provide updates to cross-functional team members including executive personnel.
  • Maintain proficiency in the latest process technologies as well as emerging development strategies.

Professional Experience/Qualifications

  • D. degree in a relevant scientific discipline
  • 8 to 10+ 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 upstream and/or downstream process development and optimization for recombinant protein production and purification.
  • Direct experience in process validation is a plus.
  • Strong problem-solving skills and ability to multitask in a fast moving and dynamic environment.
  • Ability to communicate effectively both orally and in writing, both internally and with external vendors and partners.