Director, Process Chemistry — Scale-Up & IND Readiness

Alzheon, Inc.; Framingham (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

Alzheon, Inc. is a clinical-stage biopharmaceutical company focused on Alzheimer’s disease and neurodegenerative disorders.

The Director, Process Chemistry will lead robust, scalable synthetic processes for small-molecule drug substances, guiding IND-stage development and CMC activities with internal teams and external CDMOs. The role emphasizes designing efficient routes, impurity control, process safety, and regulatory documentation, while maintaining meticulous records and enabling NDA

Qualifications

• PhD in organic chemistry or an MS/BS with relevant experience demonstrating comparable process-development capability.
• Minimum of 10 years of small-molecule process chemistry experience in a pharmaceutical or biotechnology setting.
• Strong synthetic chemistry skills and practical experience designing experiments, interpreting reaction and analytical data, and solving process-development problems.
• Working knowledge of impurity control, isolation methods, scale-up principles, laboratory safety and the documentation discipline required in regulated development.
• Experience in, or familiarity with, the CMC regulatory process and writing regulatory documents (e.g., INDs, IMPDs, NDAs).
• Clear technical writing, effective cross-functional communication and the ability to plan work, document decisions and collaborate with external partners.

Responsibilities

• Design and evaluate synthetic routes; optimize reaction conditions, yield, purity, reproducibility and material efficiency for scale-up.
• Investigate impurity formation and fate with analytical colleagues; establish practical in-process controls and support suitable analytical methods.
• Develop crystallization, isolation and drying processes that deliver consistent drug-substance quality and reliable handling.
• Assess process hazards with safety specialists, including thermal behavior, reagent compatibility and safe operating limits, before scale-up.
• Prepare technology-transfer packages and collaborate with contract development and manufacturing organizations (CDMOs) on scale-up, troubleshooting and manufacturing readiness.
• Maintain traceable experimental records and author process reports and manufacturing instructions; support current good manufacturing practice (cGMP) documentation, investigations and CMC regulatory submissions.

Skills

Cross-functional collaboration

Technical writing

Experimental design

Impurity control

Safety and scale-up

Education

PhD in organic chemistry

MS/BS with relevant experience

Job description

Alzheon, Inc. is a clinical-stage biopharmaceutical company focused on Alzheimer’s disease and neurodegenerative disorders.

The Director, Process Chemistry will lead robust, scalable synthetic processes for small-molecule drug substances, guiding IND-stage development and CMC activities with internal teams and external CDMOs. The role emphasizes designing efficient routes, impurity control, process safety, and regulatory documentation, while maintaining meticulous records and enabling NDA