Head, Analytical Development

Company: Aura Biosciences
Location: Cambridge
Posted on: May 12, 2022

Job Description:

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.

Job Summary:
Reporting to the Head of Technical Operations, the Head of Analytical Development 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.

Essential functions:
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

Qualifications:
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

Benefits and Perks:
Aura offers a great benefit package which includes:
Health insurance with FULL premium coverage
401K with company match
Competitive Paid time off (PTO)
Company-paid short & long-term disability insurance and life insurance
Daily in-office lunch provided
Free parking

Keywords: Aura Biosciences, Cambridge , Head, Analytical Development, Other , Cambridge, Massachusetts