Nearly 37 million Americans are currently affected by Chronic Kidney Disease.
37 million.
At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.
Our tenacious, passionate employees challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.
This is life-changing work, and we are all in, are you?
The Scientist II of Analytical Sciences will support all aspects of analytical development including characterization and control for drug products. 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.
Required Skills
- Provide analytical oversight of external vendors for preclinical and Phase I – III/Registration CMC activities for small molecule drug product (DP).
- Provide oversight and direction for phase appropriate development, validation and transfer of analytical methods for raw materials, in-process control samples and DP 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 DP manufactured at CMOs.
- Assisting in designing and managing phase appropriate stability studies for DP.
- Authoring analytical development sections and contributing to drug product related sections of regulatory filings.
- 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 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.
Required Experience
Basic Qualifications:
- Master’s degree or PhD in Chemistry, Pharmaceutical Chemistry or related discipline and experience in analytical method development in a CMC environment
Preferred Qualifications:
- BS 8+ years of experience, 4+ years (with MS) or 2+ years (with PhD) of experience in analytical method development in a CMC environment
- Strong analytical, communication, presentation, and writing skills
- Hands on experience with dissolution are required
- Ability to manage priorities and maintain timelines in a fast-paced environment
- Ability to exercise independent judgment with minimal supervision
- Ability to work cross-functionally
- Demonstrated ability to effectively manage outsourced analytical activities
- Regulatory experience is a plus
- TRAVEL REQUIREMENTS: Some travel may be required to various meetings or vendor sites
All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.
Requests for accommodation will be considered on a case-by-case basis, and Akebia will consider, among other things whether a proposed accommodation would create an undue hardship.
Are you an Akebian?
An Akebian is curious, empathetic, and values making connections to people and ideas.
Akebian’s aren’t afraid of diving in and owning a process or a problem, because we all want to deliver a great solution.
Akebian’s believe that we are better together because we are all working toward a common purpose – to better the life of each person impacted by kidney disease.
Akebia 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.