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.

Position Summary:

Aura Biosciences is seeking a Principal Engineer for External Manufacturing to play a critical role providing technical oversight and act as Person in Plant (PIP) for CMO operational activities related to our early and late stage programs up to commercial operations. This person is responsible for ensuring that CMO timelines for upstream, downstream, and custom starting materials manufacture stay on track and execution of GMP runs is successful to ensure clinical and commercial drug supply 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:

• Participate in the cross-functional working teams to support GMP production at CMO partners, including all activities from initial cell banking through bulk drug substance.
• 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 at CMOs 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 Partners and CMOs, where applicable
• Perform review of SOPs, batch records and supporting documentation as needed to ensure on time production and disposition

Minimum Requirements:

• Minimum of Bachelor’s Degree in Engineering or Life Sciences, with 8+ years of relevant industry experience
• Proven track record of successful CMO 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 Antibody Drug Conjugate/Vaccine manufacturing or biologics BDS/DP production
• Ability to act decisively and with urgency to solve problems
• 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
• 20% travel anticipated
• Remote candidates considered

Benefits and Perks:

Aura offers a great benefit package which includes:

• Health insurance with FULL premium coverage
• 401K with company match
• Employee Stock Purchase Program (ESPP)
• Competitive Paid time off (PTO)
• Company-paid short & long-term disability insurance and life insurance

Interested in applying? Please apply through our LinkedIn posting: https://www.linkedin.com/jobs/view/3217175699

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.

Position Summary:
Aura is seeking an experienced Analytical Data Scientist to join their Tech Ops/Analytical team. The role will broaden and deepen the company’s capabilities in the Biologics development and application of data analysis towards process development and analytical development. The role will bring in and utilize its expertise in statistical data analysis capabilities to handle analytical data generated during upstream (fermentation) and downstream (chromatographic) process development including impurity profiles and yield for multiple unit operations, and data generated during method development, qualifications, comparability etc. Candidate must have experience in analyzing and management large data sets using Excel, SQL, JMP or similar data analysis tools. Development of automated analysis tools would be a plus.

Responsibilities include but are not limited to:

• Responsible for data analysis and reporting activities for non-clinical research and development evaluation and verification.
• Apply visualization, analytical and data mining techniques.
• Analyze and manage large clinical data sets using Excel, SQL, JMP or similar data analysis tools.
• Able to examine data sets and determine the best end-to-end analysis plan to address key business questions and proactively identifies opportunities for product improvements.
• Provide specialized functions such as algorithm development, statistical modeling, or data analysis methodology.
• Serve as Process/analytical database manager for research and development activities within Technical Operation Function.

Minimum Requirements:

• Minimum 4 years in a relevant industrial setting focused on biologics development.
• Experienced with data analysis and software programming.
• Able to perform proficiently under up-to-date regulatory requirements.
• Minimum Education: MS or Ph.D. in bioanalytical, biostatistics, biomedical engineering, chemical engineering, or a relevant physical or biological sciences.

Desired Qualifications

• Proficient with Statistical analysis tools.
• Experienced in data analysis and reporting activities, with strong problem-solving and critical thinking skills.
• Capable of solving analytical problems and effectively communicating methodologies and results, to support analytical and product development.
• Excellent communication, presentation, and organizational skills.
• Capable of independently driving issues to resolution.
• Collaborate effectively with internal stakeholders and cross-functional teams.
• Early/late-stage clinical development experience is a plus.

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

Interested in applying? Please apply through our LinkedIn posting: https://www.linkedin.com/jobs/view/3114086932

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.

Position Summary:

Aura Biosciences is seeking a CMC Project Manager to play a critical high-level role providing strategic oversight of process transfers from internal to external contract manufacturing sites. This person is responsible for ensuring that CMO timelines for upstream, downstream, and custom starting materials manufacture stay on track.

The successful candidate will have a demonstrated track record of technical and project leadership. 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:

• Overseeing the planning and execution of project activities to ensure alignment with the expectations and timelines.
• Provide continuous support for teams to proactively plan project activities as well as track and monitor project progress.
• Manage projects, critical path items, and project risks.
• Develop project timelines and budgets based on detailed project plans.
• Escalate timeline slips and risk quickly and efficiently.
• Ability to build strong relationships and take a lead role with external collaborators on complex, multi-national research, and development stage projects.
• Partner proactively with the Project Leader and team members to identify risks, gaps, and resource bottlenecks and then develop and implement mitigation plans.

Minimum Requirements:

• BS degree required, MS degree or MBA preferred
• 5-7 years prior experience with project management tech transfer to a CMO.
• Ability to be self-disciplined and individual accountably for delivering.
• Ability to acknowledge timeline slips and escalate in a timely matter when they occur.
• Adaptability and positive attitude in a fast-paced environment
• Ability to communicate effectively both orally and in writing, both internally and with external vendors and partners

Interested?  Email a cover letter and a copy of your CV to recruiter@aurabiosciences.com referencing the position description in the subject line.

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.

Position Summary:

The Principal Scientist-Characterization is a key strategic and leadership role in the Analytical Development (AD) Department at Aura where the candidate will contribute by planning and performing product characterization through development of state-of-the-art analytical methods and generating data to meet regulatory expectations for the Biological License Application (BLA) of the lead Aura product, AU-011. The data will be used in the module 3 Product Characterization and hence the successful candidate will bring the expertise to develop the characterization plan and draft the dossier section.

Demonstrable knowledge in multiple cutting edge analytical technologies and specific expertise in LC and Mass Spectrometry is important. The candidate needs to be an excellent communicator and prior knowledge in managing CROs to get the work done within very aggressive timeline.

This role is expected to spend 50% time at the bench and the remaining time managing characterization work with collaborators (academics/CROs).

Responsibilities include but are not limited to:

• Act as the subject matter expert in Analytical Development to support all 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
• Develop and execute Reference Standard material qualification strategy with Quality Control
• Independently design and manage execution of experiments 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
• 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

Knowledge, Skills & Capabilities:

• In depth understanding and hands on experience in one or more of the following areas are required: Peptide Mapping, LC/MS-MS, Flow Cytometry, FTIR, Electron Microscopy, etc.
• The ability to use and maintain LC-MS/MS instrumentation, and interpret the data generated
• Experience analyzing complex biological samples via mass spectrometry
• Good understanding of biopharma operations, GXPs, ICH guidelines, process characterization/validation and technology transfer
• Knowledge and/or Perform FTIR Spectroscopy
• 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 comprehensive and accurate protocols/reports
• Ability to function independently and communicate cross-functionally across various departments
• Ability to manage priorities, and engage/communicate in a multidisciplinary environment

Education & Relevant Work Experience:

• PhD in a relevant scientific and biological discipline e.g., Analytical Chemistry /Biochemistry /Chemistry with 10+ years of industry experience, or master’s degree with 15+ years of industry experience
• Experience in analytical development and characterization of antibody-drug conjugate, viral vectors or other biologics (3+ years)

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
• Free parking

Physical & Travel Requirements:

• Travel to CTLs and CROs, as needed (<20%)

Interested?  Please apply through our LinkedIn posting: https://www.linkedin.com/jobs/view/3189881500