Associate Director, Synthetic Organic Chemist, MSAT

Aura Biosciences•Boston, MA

22h•$170,000 - $215,000

About The Position

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 aurabiosciences.com. Follow us on X, @AuraBiosciences, and visit us on LinkedIn. 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.

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.

Nice To Haves

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

Responsibilities

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.