Director, Process Chemistry

• DepartmentCMC
• Position Type Full-Time
• Location Hybrid (Framingham, MA)

Company Overview

Alzheon, Inc. is a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer's disease and other neurodegenerative disorders. We are committed to developing innovative medicines by directly addressing the underlying pathology of devastating neurodegenerative disorders. Our lead Alzheimer's clinical candidate, ALZ-801, is an oral agent in Phase 3 development as a potentially disease modifying treatment for AD. ALZ-801 is an oral small molecule that fully blocks formation of neurotoxic soluble amyloid oligomers in the brain. Our clinical expertise and technology platform are focused on developing drug candidates and diagnostic assays using a precision medicine approach based on individual genetic and biomarker information to advance therapies with the greatest impact for patients.

Our experienced and passionate drug development team is focused on applying precision medicine, cutting-edge disease biomarkers, brain imaging and unique biologic insights to advance therapies with the greatest impact for patients. We are seeking individuals with an entrepreneurial spirit to join our team and help make the first oral Alzheimer's disease-modifying therapy a reality for patients and their families, in a few short years.

Position Overview

Alzheon is seeking a Director, Process Chemistry to develop robust, scalable synthetic processes for small-molecule drug substances in development. Working with analytical, quality and chemistry, manufacturing and controls (CMC) colleagues and external manufacturing partners, this role will oversee the development of new candidates into the IND stage and support CMC development of clinical-stage candidates across clinical, regulatory and GMP quality activities through NDA readiness.

The ideal candidate will be able to oversee and direct robust chemical process development and implement the supporting technical documentation.

Key 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

Requirements

• PhD in organic chemistry or a related discipline, 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

Preferred Qualifications

• Experience leading small-molecule process chemistry development projects at the IND and clinical stages
• Experience directing and overseeing CDMO manufacturing campaigns or cGMP process documentation
• Experience with design of experiments, reaction kinetics, process analytical technology, solid-state characterization or process calorimetry
• Familiarity with phase-appropriate process controls, impurity risk assessments and CMC regulatory documentation

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.