Scientist II, Analytical Development
CMC / Technical Operations
The Scientist II of Analytical Development will support all aspects of analytical development including characterization and control for drug substances. Knowledge of a broad range of analytical techniques commonly used in the analysis of pharmaceuticals and experience in method development, transfer and validation are required.
- Provide analytical oversight of external vendors for preclinical and Phase I - commercial CMC activities for small molecule drug substance (DS).
- Provide oversight and direction for phase appropriate development, validation and transfer of analytical methods for raw materials, in-process control samples, and DS at CMOs.
- Excellent problem-solving skills are required.
- Participate in the development and revision of product specifications, provide scientific input and critique analytical results.
- Review the quality control testing of clinical trial supplies manufactured at CMOs.
- Manage stability studies for DS.
- Participate in the preparation of CMC sections of regulatory submissions along with other functional groups.
- Ensure compliance with analytical requirements for CMC regulatory submissions.
- Familiarity with a broad range of analytical techniques for characterization of pharmaceuticals including thermal methods, HPLC & GC with a variety of detection methods, wet chemical analysis (e.g., KF, dissolution, etc.), spectroscopic techniques, particle size, and heavy metal analysis.
- Understand the drug substance and drug product development process, and their impact on analytical method development, validation strategies and specifications.
- Participate in analytical investigations for deviations/OOS/OOT and ensure proper corrective actions are taken.
- Performs other duties as assigned.
- PhD in Chemistry, Pharmaceutical Chemistry or related discipline with 2+ years of experience in analytical method development in a CMC environment
- Master’s degree in Chemistry, Pharmaceutical Chemistry or related discipline with 4+ years of experience in analytical method development in a CMC environment
- BS in Chemistry, Pharmaceutical Chemistry or related discipline with 8+ years of experience in analytical method development in a CMC environment
- TRAVEL REQUIREMENTS: Some travel may be required to various meetings or vendor sites
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people with kidney disease. The company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com.
Akebia Therapeutics is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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