As a core member of the CMC leadership team, provide scientific input for the development of APIs and drug products in compliance with FDA/ICH requirements.
Provide leadership and direction for Analytical Development and Quality Control functions including directing analytical method development, validation and QC testing at contract facilities.
Oversee quality programs for APIs and drug products, including setting specifications, analyzing data for shelf-life prediction, and preparing associated protocols, reports and regulatory submissions.
Participate in planning and strategy for CMC scientific and regulatory approach for Cassava’s development pipeline.
Contribute to preparation of CMC regulatory submissions for INDs/NDAs and briefing documents for US or international regulatory agencies.
Lead the development and validation of analytical methods for Cassava’s product candidates according to FDA/ICH Guidances.
Recommend and oversee appropriate stability studies for API and Drug Product. Write stability protocols, analyze results in support of formulation development and quality assurance of clinical drug. Present analytical data with appropriate statistical analyses for specification setting, recommendations of shelf-life, CMC investigations, lot disposition.
Oversee Cassava’s providers of contracted chemistry and analytical testing services. Participate in GMP compliance auditing to assure development, manufacturing and analytical testing for APIs and drug products is being conducted according to appropriate standards.
Prepare QC documents including analytical test procedures, certificates of analysis, specifications, QC investigations, stability reports and CMC regulatory submissions.
This position requires an understanding of FDA and ICH CMC/Quality Guidances which will be applied to development of Cassava’s API and drug product candidates. Successful applicants are expected to have academic training and industrial experience in Analytical Development and Quality Control to lead this function with minimum guidance and contribute collaboratively as a core member of the CMC leadership team.
Education/Special Knowledge and Skills
This position requires strong technical skills in analytical and/or organic chemistry, effective written skills to prepare regulatory submission documents, and demonstrated industrial experience with cGMPs and FDA/ICH regulations. Additionally, the candidate in this position must have an ability to work effectively in teams within CSI, and with outside contractors. An advanced degree in a chemistry discipline is required.
Additional Salary Information: Cassava compensation includes a comprehensive benefit package including the potential for equity awards.
Internal Number: Tech Ops 01
About Cassava Sciences, Inc.
Cassava Sciences, Inc. (Nasdaq: SAVA), is a clinical-stage biotechnology company headquartered in Austin, Texas.
Our mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. Over the past 10 years, Cassava Sciences has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for diagnosis and treatment of Alzheimer’s disease.