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