Associate Director, Synthetic Organic Chemist, MSAT

Aura Biosciences is a clinical-stage biotechnology company developing bel-sar, a potentially transformative, first-in-class therapy for patients living with ocular cancers. Bel-sar represents an entirely novel approach to treating ocular cancers via its dual mechanisms of action of acute tumor necrosis and secondary anti-tumor immune activation. The Phase 3 registration study of Bel-sar in early choroidal melanoma, the largest patient segment of uveal melanoma, is fully enrolled, and earlier stage studies in metastases to the choroid and cancers of the ocular surface are ongoing.

Aura's mission is to improve outcomes for patients living with ocular cancers by delivering a therapy that not only arrests tumor growth but also preserves vision and quality of life.

For more information, visit  Follow us on X, @Aura Biosciences, and visit us on Linked In.

Reporting to the Senior Director of Process Development and MSAT, the Associate Director will be responsible for the development of a new synthetic process to manufacture the company’s critical dye (API). Once successful, the incumbent will work within our MSAT team to support scale up, tech transfer and commercialization of the process in a cGMP facility at our CDMO. This individual will interact with internal cross-functional teams and CRO/CDMO to ensure timely progress in technology development, documentation, and manufacturing readiness.

This role sits within Aura’s Technical Operations organization, supporting dye/API process development from initial route design through regulatory filing commercial readiness.

• Lead the development of a new synthetic organic chemistry process, executed at external CDMO/CRO partners supporting our novel virus-like drug conjugate program
• Drive the design, review, approval and execution of external protocols and experiments
• Analyze external experimental data to drive synthetic experimental plans at CRO’s and CDMO’s
• Provide chemistry-specific technical support to MSAT during scale-up of the synthetic process to a suitable manufacturing scale
• Support tech Transfer of the scaled up synthetic process from development to GMP with chemistry-specific technical input
• Establish control strategies for process impurities and degradants
• Evaluate synthetic routes and recommend improvements to enhance process robustness, efficiency, safety, and scalability.
• Provide scientific assessments of potential mutagenetic impurities and other impurities of concern
• Define critical quality attributes and specifications
• Provide chemistry-specific input to support assessment of the impact of any process changes and deviations during GMP manufacturing
• Author and review CMC sections of relevant regulatory submissions (e.g., IND, NDA/BLA Module
  3)
• Lead scientific evaluation of regulatory starting material selection and justification
• Evaluate reagent, solvent, intermediate, and raw material considerations from a process chemistry perspective
• Collaborate with Analytical Development to define analytical method needs and support impurity characterization Contribute to process hazard and safety assessment in support of scale-up activities
• Work with cross-functional teams across Tech ops, Quality and Regulatory ) and CDMO partners to identify risks) that could impact program timelines.

• PhD or MS in Organic Chemistry, Process Chemistry, Pharmaceutical Sciences, Engineering or related discipline
• Minimum 10 years hands-on synthetic organic chemistry experience
• Additional experience in CMC Tech Transfer and Scale-up for API products and/or biologics a plus
• Experience in working with third-party CDMO partners to develop and manufacture API products
• Familiari…