Associate Director, Synthetic Organic Chemist, MSAT

Aura Biosciences

. Lead the development of a new synthetic organic chemistry process, executed at external CDMO/CRO partners supporting the novel virus-like drug conjugate program .

Posted 10/1/2026full-timeBrighton • Massachusetts • United StatesSenior💰 $170,000 - $215,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in synthetic organic chemistry, including process development, scale-up, and tech transfer for API products. Proficient in regulatory documentation and compliance with cGMP standards, with strong analytical and problem-solving skills.

Highest-signal resume keywords

Synthetic Organic ChemistryCMC Tech TransferRegulatory Documentation (IND, NDA/BLA)Quality by Design (QbD)Analytical Method Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Synthetic Route EvaluationProcess Robustness OptimizationImpurity Control StrategiesAPI Drug Substance DevelopmentAnalytical Procedures (UV/VIS, RP-HPLC, Mass Spec, NMR)Process Safety AssessmentScale-Up of Synthetic ProcessesChemical Modifications UnderstandingProblem Solving in SynthesisTechnical Oversight of Chemistry Development

Soft Skills

Strong Communication SkillsRelationship BuildingOrganizational SkillsDetail OrientedProblem Solving

Tools & Technologies

MS ExcelJMPMS PowerPointMS Word

Industry Keywords

CGMP RequirementsICH GuidelinesAPI ProductsCDMO/CRO CollaborationProcess Hazard Screening

About the role

Key responsibilities & impact

Lead the development of a new synthetic organic chemistry process, executed at external CDMO/CRO partners supporting the 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
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 mutagenic impurities and other impurities of concern
Define critical quality attributes and specifications
Provide chemistry-specific input to support assessment of process changes and deviations during GMP manufacturing
Author and review CMC sections of relevant regulatory submissions, including IND and 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 for scale-up activities
Work with cross-functional teams across Tech Ops, Quality, Regulatory, and CDMO partners to identify risks impacting program timelines

Requirements

What you’ll need

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
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

Benefits

Comp & perks

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