Associate Director, Synthetic Chemistry & Process Scale-Up

Aura Biosciences, Inc.; Boston (MA); On-site; USD 170,000 - 215,000; Full time

Benefits offered by this job

Health insurance

401K with company match

Employee Stock Purchase Program (ESPP)

Paid time off (PTO)

Disability & life insurance

Job summary

Aura Biosciences, Inc. is seeking an Associate Director of Process Development to lead a new synthetic dye/API process at external CDMOs and drive tech transfer to GMP. You will partner with MSAT, QA, and Regulatory to ensure robust, scalable chemistry for ocular cancer therapies.

You will guide external partners, assess data, and shape impurity control strategies while contributing to IND/NDA documentation and process improvements in a fast-paced biopharma setting.

Qualifications

• PhD or MS in Organic Chemistry, Process Chemistry, Pharmaceutical Sciences, Engineering or related discipline.
• Minimum 10 years hands-on synthetic organic chemistry experience.
• Experience with CMC Tech Transfer and scale-up for API products or biologics is a plus.
• Experience with third-party CDMOs/CROs for API development and manufacture.
• Familiarity with cGMP requirements and impurity control guidelines.
• Experience authoring CMC/regulatory documentation (IND/NDA/BLA Module 3).
• Ability to manage external partners with independent data review and oversight.
• Knowledge of Quality by Design (QbD) and Design of Experiments (DOE) principles.
• Strong problem-solving, organizational, and cross-functional communication skills.

Responsibilities

• Lead development of a new synthetic organic chemistry process at external CDMO/CRO partners.
• Drive protocol design, review, approval, and execution of external experiments.
• Analyze external data to inform synthetic plans at CROs/CDMOs.
• Provide chemistry input to MSAT during scale-up to manufacturing scale.
• Support tech transfer of scaled-up processes to GMP with input on chemistry.
• Establish control strategies for impurities and degradants.
• Evaluate routes and propose improvements for robustness and scalability.
• Write and review CMC/regulatory submissions and starting material justifications.
• Collaborate with Analytical Development to define impurity methods and risk assessments.
• Work with cross-functional teams to identify and mitigate program risks.

Skills

Synthetic organic chemistry

DOE/QbD

External CDMO oversight

Regulatory/compliance input

Cross-functional collaboration

Written communication

Process development planning

Scale-up readiness

Education

PhD or MS in Organic Chemistry/related field

Tools

Excel

JMP

PowerPoint

Word

Job description

Aura Biosciences, Inc. is seeking an Associate Director of Process Development to lead a new synthetic dye/API process at external CDMOs and drive tech transfer to GMP. You will partner with MSAT, QA, and Regulatory to ensure robust, scalable chemistry for ocular cancer therapies.

You will guide external partners, assess data, and shape impurity control strategies while contributing to IND/NDA documentation and process improvements in a fast-paced biopharma setting.