Principal Scientist, Drug Product Development
Location: Cambridge, MA
Type: Full-Time/Regular
Job ID: 24R-19
At Akebia, nearly 37 million Americans are affected by Chronic Kidney Disease. We are committed to improving their lives through innovative therapeutics. Join us in this life-changing work.
Position Summary
Reporting to the Sr Director, Drug Product, the Principal Scientist will provide strategic and technical leadership within the CMC Technical Operations team. Responsibilities include pre-formulation process characterization, formulation development, manufacturing process development, process scale-up, technology transfers, and supporting global drug product manufacturing. The role involves ensuring timely delivery of clinical and commercial drug inventory, supporting regulatory submissions, and maintaining compliance across all activities.
Key Responsibilities
- Lead development and optimization of drug product strategies for clinical and commercial programs.
- Manage project teams, timelines, contracts, and budgets.
- Collaborate with cross-functional teams to support program goals.
- Oversee activities at contract manufacturing organizations worldwide.
- Ensure timely production of drug inventory for clinical and commercial use.
- Author and review technical protocols, reports, and validation documentation.
- Employ Continuous Process Verification principles to analyze manufacturing data and drive improvements.
- Hire, mentor, and develop the drug product team.
- Support regulatory submissions with technical documentation.
- Represent the Drug Product organization on project teams.
Minimum Qualifications
- Bachelor's, Master's, or Ph.D. in Organic Chemistry, Biochemistry, Chemical Engineering, or related field.
- 10+ years of relevant experience.
- 5+ years in small-molecule solid oral and parenteral drug development.
Preferred Qualifications
- Experience with lifecycle management of commercial-phase drug products.
- Expertise in pre-formulation characterization and process development.
- Experience managing activities at contract development and manufacturing organizations.
- Proficiency in drafting protocols, reports, and regulatory documents.
- Knowledge of GMPs, ICH guidelines, and global regulatory requirements.
- Strong leadership, collaboration, and communication skills.
Compensation
Base salary range: $149,858 - $185,119, depending on experience and qualifications. Additional benefits include bonuses, equity, health care, PTO, and retirement plans.
About Akebia
We are dedicated to bettering the lives of those impacted by kidney disease. Join our team of curious, empathetic individuals committed to making a difference. Learn more atwww.akebia.com.
Akebia is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
