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
Click
here to apply!
|