Associate Director, Synthetic Organic Chemist, MSAT

About Aura Biosciences:

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. Auras 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 @AuraBiosciences and visit us on LinkedIn.

Position Summary:

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 companys 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 Auras Technical Operations organization supporting dye/API process development from initial route design through regulatory filing commercial readiness.

Responsibilities include but are not limited to:

• 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 CROs and CDMOs
• 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.

Minimum Requirements:

• 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
• Familiarity with cGMP requirements
• Demonstrated experience evaluating and optimizing synthetic routes for process robustness and scalability
• Knowledge of applicable ICH guidelines relevant to impurity control and starting material justification
• Experience authoring or contributing to CMC/regulatory documentation (e.g. IND NDA/BLA Module 3 sections)
• Experience providing technical oversight of chemistry development conducted at external CDMOs/CROs including independent review of process and analytical data without direct laboratory access.
• Experience applying Quality by Design (QbD) and Design of Experiments (DOE) principles to process development and control strategy
• Highly organized detailed oriented with strong problem solving and analytical skills.
• Ability to build strong relationships with cross-functional team members and with external CDMOs.
• Ability to work independently manage priorities meet agreed timelines adapt to evolving priorities and thrive in a fast-paced environment.
• Ability to communicate effectively and professionally both orally and in writing with internal and external partners.
• Ability and willingness to travel as required.

Desired Qualifications:

• In-depth understanding of synthetic organic methodologies and development of API drug substance by multiple unit operation step preparations.
• Strong understanding of solvent extractions purifications and drying processes
• Real life examples of synthetic problem solving and effectively avoiding known synthetic pitfalls
• Proven experience scaling up synthetic processes
• Experience developing impurity fate and purge strategies
• Understanding of chemical modifications resulting from light exposure
• Experience with various analytical procedures and results is preferred (UV/VIS RP-HPLC Mass Spec NMR etc.)
• An understanding of US and EU current good manufacturing practices (cGMPs) as they apply to the development and qualification of API products
• Proficient in MS Excel JMP MS PowerPoint and MS Word applications.
• Familiarity with process safety and reactive chemistry hazard screening (e.g. DSC ARC calorimetry) is a plus

Salary & Benefit Information:

Salary Range: $170000/yr - $215000/yr

(Placement within the listed range depends on many factors including but not limited to: geographic location degree years of experience and internal company equity)

Health insurance with FULL premium coverage

401K with company match

Employee Stock Purchase Program (ESPP)

Unlimited paid time off (PTO)

Company-paid short & long-term disability insurance and life insurance

Required Experience:

Director