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About Aura:
At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies.
We are focusing the initial development of our VDC technology platform to treat tumors of high unmet need in ocular and urologic oncology. AU-011, our first VDC candidate, is being developed for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved. Beyond primary choroidal melanoma, we are developing AU-011 in additional ocular oncology indications, including choroidal metastases. Leveraging our VDCs’ broad tumor targeting capabilities, we also plan to initiate a clinical program in non-muscle invasive bladder cancer, or NMIBC, our first non-ophthalmic solid tumor indication.
Position Summary:
Aura Biosciences is seeking a Validation Manager to contribute to the overall success of our novel therapy. This position will support the organization through the establishment of Aura’s process validation program and ensure alignment with industry standards in accordance with the relevant product’s lifecycle. The successful candidate will work closely with Process Development, MS&T, QC and QA functions in ensuring the success of the Process Performance Qualification (PPQ) campaign leading to commercial manufacture. The successful candidate must be able to troubleshoot complex validation issues and apply advanced validation engineering and scientific principles to the design and implementation of process or system modifications. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success. In this position you will also be responsible for guidance and technical review of protocols and reports related to process validation. These activities will encompass IND-enabling, pre-clinical, clinical and commercial projects. The successful individual will own, lead or support multidisciplinary, multi-site, complex projects.
Responsibilities include but are not limited to:
Minimum Requirements:
Success Factors:
Full Time
$96k-111k (estimate)
04/18/2024
06/16/2024
aurabiosciences.com
Cambridge, MA
<25
The job skills required for Validation Manager include Leadership, Project Management, Alignment, Collaboration, Initiative, Microsoft Office, etc. Having related job skills and expertise will give you an advantage when applying to be a Validation Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Validation Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Validation Manager positions, which can be used as a reference in future career path planning. As a Validation Manager, it can be promoted into senior positions as a Validation Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Validation Manager. You can explore the career advancement for a Validation Manager below and select your interested title to get hiring information.