MSAT Scientist, External Manufacturing

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 MSAT Scientist to play a critical role providing technical oversight and act as Person in Plant (PIP) for CDMO operational activities related to our early and late-stage programs up to commercial operations. This person is responsible for ensuring that CDMO timelines for the manufacture of Aura’s small molecule and Drug Product manufacturing stay on track and execution of GMP runs is successful to ensure clinical and commercial needs are met. This person serves as the key point of contact between Aura SMEs and vendor SMEs. The successful candidate will have a demonstrated track record of technical GMP manufacturing oversight through to product disposition. This is an excellent opportunity for a highly motivated self-starter and creative problem solver who has a strong desire to make an important contribution to the development of novel therapies. This is a high-profile position with the opportunity to innovate in an entrepreneurial and high growth organization.

Responsibilities include but are not limited to:

• The primary focus of this position will be on cGMP manufacturing of a small molecule which, once released, is conjugated to a virus like particle.
• Participate in the cross-functional working teams to support GMP synthesis, purification and characterization of complex API targets at CDMO.
• Build business processes and cross-functional relationships with internal/external partners. This includes applicable metrics and program-tracking to ensure adherence to contractual obligations.
• Author and/or review of Quality System documentation, including technical reports, deviations and change controls. Provide manufacturing technical expertise in meetings related to QMS documentation and drive to closure.
• Act as PIP providing front-line support for process or equipment related issues and ensure cross-functional engagement internally.
• Regular collaboration with QA, QC, PD and AD for tech transfer, process qualification and method validation.
• Responsible for negotiating, monitoring, and maintaining Agreements with CDMOs.
• Perform review of SOPs, batch records and supporting documentation as needed to ensure on time production and disposition.
• Support the execution of a successful process validation campaign utilizing contemporary risk assessment and control strategy frameworks as established in various regulatory guidelines to support launch of commercial manufacturing.
• Develop, and lead comprehensive FMEA “Failure Modes and Effects Analysis” for current and future processes
• Compile, generate and review process inputs and outputs using statistical process control measures for product quality and process consistency reports.
• Facilitate multiple aspects of an API process qualification strategy through designing/authoring/executing/reporting/investigating of process qualification studies.
• Contribute knowledge and ideas for the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification, and control of impurities.
• Familiar with characterization and analysis of organic small molecules using techniques including high performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), nuclear magnetic resonance (NMR), Karl Fischer titration (KF), infrared spectroscopy (IR), UV-visible absorption spectroscopy and fluorescence emission spectroscopy.
• Familiarity with physicochemical characterization methods employed for active pharmaceutical ingredients (API) i.e., X-ray Powder Diffraction (XRPD), Differential Scanning Calorimetry (DSC), Particle Size Analyzer, Optical Microscope and Scanning Electron Microscope (SEM) is considered an asset.

Minimum Requirements:

• BSc or MSc in Chemistry, Biochemistry or Pharmaceutical Sciences with 4+ years of hands-on experience and exposure to organic chemistry; particularly to synthesis, isolation and characterization of organic molecules
• Proven track record of successful CDMO management experience supporting early and late-stage programs
• Strong knowledge of current Good Manufacturing Practices (GMP) and Global regulatory requirements
• Experience in authoring and reviewing CMC sections of BLAs and previous launch experience preferred
• Experience with organometallic chemistry and liquid DP production is desired
• Ability to act decisively and with urgency to solve problems
• Detail oriented and ability to interpret complex information via excellent oral and written communications with ability to present data to all levels of expert and non-expert audiences
• Accountability and self-awareness to drive positive results
• Effective organizational and planning skills
• Aligned with Aura core values of collaboration, respect, innovation and teamwork.
• 20% travel anticipated