Reports to: Head of Technical Operations
Location: Cambridge, MA
Reporting to the Head of Technical Operations, the Head of Analytical Sciences is responsible for analytical development activities within the CMC department at Aura Biosciences. This individual will serve as a subject matter expert within analytical development and provide technical expertise in support of drug development programs as they advance to and through the clinic. The incumbent will manage analytical development activities across all stages of drug development, making significant contributions to project teams.
To perform this job successfully, the individual must be able to perform the following:
- Manage analytical development activities across all stages of drug development
- Routinely oversee and participate in the invention, qualification, development and validation of cell based, biochemical, physicochemical, immunochemical and other methods required to support CMC
- Oversee release testing, stability and comparability studies using appropriate statistical tools for the analysis of analytical data
- Review and approve analytical results, protocols, reports, and analytical investigations
- Collaborate with CMO/CRO partners and with internal clinical, quality and regulatory teams; write technical reports and documents in support of regulatory filings
- Generate analytical data packages and communicate results effectively with executive members to support product development activities
- Manage external contractors for assay transfer, qualification, development, validation and routine analysis, to support projects
- Author and technical review assay development and assay transfer documents ensuring good quality guidelines are adhered to throughout
- Give technical guidance and training to other laboratory staff as required
- Communicate, work closely and provide analytical updates to cross-functional team members including executive personnel
- Maintain proficiency in the latest analytical technologies as well as emerging analytical development strategies
The ideal candidate will offer:
- PhD degree in a relevant scientific discipline
- 10+ years of experience in the biotech or pharmaceutical industry with an emphasis on protein-based therapeutics/vaccines, etc.
- Expertise in analytical method development, technology transfer, and validation
- Demonstrated knowledge of phase appropriate pharmaceutical analytical development (spanning R&D process, regulatory support, etc.)
- Adaptability and positive attitude in a fast-paced environment
- Strong organizational skills with ability to prioritize personal and direct reports workload
- Ability to communicate effectively both orally and in writing, both internally and with external vendors and partners
At Aura Biosciences, we are developing a new class of therapies based on a 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 choroidal melanoma is designed to kill cancer cells in the choroid and our expectation is that this will be utilized as a first-line therapy, potentially earlier than radiotherapy that has a large number of side effects. Come help develop a first-in-class treatment to selectively destroy cancer cells!