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 Senior Scientist is a newly created role in our Technical Operations team and will be responsible for process research and development including manufacture of drug substance material, process development and process scale up.
Experience providing oversight of research and manufacturing outsourced to third party vendors is preferred.
Required Skills
- Manages drug substance development and manufacturing activities (Phase 1 – 3) at external laboratories and contract manufacturing facilities for small molecule drug substances.
- Collaborate with CMC and partner function lines, including discovery, process development, analytical development, quality and regulatory to achieve project deliverables and timelines.
- Coordinates with project team to implement plans for timely delivery of clinical materials.
- Conducts phase appropriate process development and manages drug substance campaigns at external CMOs.
- Provides scientific guidance to CMO’s and helps trouble-shooting development and production issues.
- Participates in the development and revision of in process tests and product specifications.
- Write and review drug substance-related sections for regulatory filings.
- Independently writes technical development reports.
- Review and approve documentations from external CMOs including documents related to GMP operations, development reports, Master Batch Records, Executed Batch Records, campaign summary reports, and stability summary reports.
- Travel to various CMO sites (up to 25%).
Required Experience
Basic Requirements:
- B.S.
degree with drug development experience
Preferred:
- Ph.D.
degree in organic chemistry, or related scientific discipline with 3+ years of pharmaceutical drug development experience
- M.S degree with 5+ years of pharmaceutical drug development experience
- B.S degree with 8+ years of pharmaceutical drug development experience
- Proven track record in developing and implementing robust and efficient drug substance manufacturing processes.
- Demonstrated knowledge of regulatory requirements for drug substance submissions.
- Strong communication, presentation, and writing skills.
- Ability to plan, organize and manage multiple projects simultaneously.
- Strong ability to exercise independent judgment.
- Ability to work cross-functionally and in virtual teams.
- Demonstrated ability to effectively manage outsourced GMP manufacturing.
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.