- Act as the subject matter expert (SME) in Biophysical Method Development to establish methods internally and support analytical characterization work for drug substance and drug product.
- Collaborate with Contract Research Organization (CROs) and Contract Testing Laboratories (CTLs) to support product characterization activities during late-stage development including process validation batches.
- Design studies with internal Analytical Development and CROs/CTLs for virus like particle (VLP) and small molecule analytical characterization to support product licensing.
- Execute Reference Standard material qualification with AD and QC (Quality Control)
- Independently design and manage execution of experiments internally and at external partners to generate robust analytical data and work collaboratively with CDMO/CROs on design and execution of experiments.
- Author and review technical protocols and reports, CMC regulatory sections, assay summaries, study design and protocols, SOPs, etc.
- Ensure accurate and complete documentation of any data, scientific experimental plan, and report.
- Maintain equipment quality through IQ/OQ and PM
- Build and maintain good working relationships with internal and external stakeholders e.g., Pre-clinical Research, Process Development, Quality Control, Suppliers, CDMOs, CROs etc.
- Independently analyze data, present results and conclusions to the team and senior management
- Establish and maintain familiarity with contemporary industrial standards, practices, technologies, literature and ways of performing lab studies
- In depth understanding and hands on experience in one or more of the following areas are required: Analytical Ultracentrifugation (AUC), FlowCam, Nanoparticle Tracking Analysis (NTA), Microflow Imaging (MFI), Circular Dichroism (CD), FTIR, Electron Microscopy (TEM/CyroTEM), etc.
- The ability to use and maintain instrumentation, and interpret the data generated.
- Good understanding of biopharma operations, GXPs, ICH guidelines, process characterization/validation and technology transfer
- People and project management skills
- Strong communication skills
- Critical thinking and problem-solving skills
- Strong technical writing skills
- Managing multiple projects and tasks and meet deadlines with a high tolerance for ambiguity
- Author and approve protocols/reports
- Ability to function independently and communicate cross-functionally across departments
- Ability to manage priorities, and engage/communicate in a multidisciplinary environment
- Principal Scientist: PhD in a relevant scientific and biological discipline e.g., Analytical Chemistry /Biochemistry /Chemistry with 8+ years of industry experience, or master's degree with 12+ years of industry experience in relevant field
- Senior Scientist: PhD in a relevant scientific and biological discipline e.g., Analytical Chemistry /Biochemistry /Chemistry with 5+ years of post-doctoral/industry experience, or master's degree with 12+ years of industry experience in relevant field
- Experience in analytical development and characterization of particles, antibody-drug conjugate, viral vectors, or other biologics (5+ years)
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Senior/Principal Scientist- Biophysical Characterization - Brighton, United States - Aura Biosciences
Description
Job Description
Job DescriptionSalary: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:
The Senior/Principal Scientist- Biophysical Characterization is a key technical leadership role in the Department of Analytical Development (AD) at Aura Biosciences where the candidate will contribute by developing methods and performing product characterization through state-of-the-art biophysical methods and generating data to meet regulatory expectations for the Biological License Application (BLA) of Belzupacap sarotalocan, (Bel-sar, AU-011). The data will be used in the module 3 product characterization. Successful candidate will bring the expertise to develop biophysical methods, characterization plan and draft the dossier section.
Demonstratable knowledge in multiple cutting edge analytical biophysical technologies and specific expertise in Particle characterization (e.g., AUC, EM, NTA) is important. The candidate needs to be an excellent communicator; prior knowledge of managing internal group and CROs is essential to be successful within very aggressive timeline.
This role is expected to spend 70% time managing internal lab work and the remaining time managing characterization work with collaborators (academics/CROs).
Responsibilities include but are not limited to:
Knowledge, Skills & Capabilities:
Education & Relevant Work Experience:
