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- Tasks: Lead drug product development and manage project teams for innovative therapeutics.
- Company: Akebia is dedicated to improving lives affected by Chronic Kidney Disease through innovative solutions.
- Benefits: Enjoy competitive salary, bonuses, equity, health care, PTO, and retirement plans.
- Why this job: Make a real impact in healthcare while working with a passionate and diverse team.
- Qualifications: Requires a degree in Chemistry or related field and 10+ years of relevant experience.
- Other info: Join a company that values diversity and inclusivity in the workplace.
The predicted salary is between 100000 - 130000 £ per year.
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. Akebia is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Principal Scientist, Drug Product Development employer: Akebia Therapeutics
Contact Detail:
Akebia Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Scientist, Drug Product Development
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who have experience in drug product development. Attend relevant conferences or seminars where you can meet potential colleagues and learn about the latest trends in the field.
✨Tip Number 2
Familiarise yourself with Akebia's current projects and therapeutic areas, particularly in Chronic Kidney Disease. This knowledge will help you demonstrate your genuine interest in the company and its mission during any discussions.
✨Tip Number 3
Prepare to discuss your leadership experiences and how you've successfully managed project teams in the past. Highlight specific examples where you led drug product strategies or collaborated with cross-functional teams to achieve goals.
✨Tip Number 4
Stay updated on regulatory requirements and guidelines related to drug product development. Being knowledgeable about GMPs and ICH guidelines will not only boost your confidence but also show that you're well-prepared for the role.
We think you need these skills to ace Principal Scientist, Drug Product Development
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and qualifications for the Principal Scientist position. Tailor your application to highlight relevant experience in drug product development and leadership.
Highlight Relevant Experience: In your CV and cover letter, emphasise your 10+ years of relevant experience, particularly in small-molecule solid oral and parenteral drug development. Use specific examples to demonstrate your expertise in pre-formulation characterization and process development.
Showcase Leadership Skills: Since the role involves managing project teams and mentoring staff, be sure to include examples of your leadership experience. Discuss how you've successfully led teams, managed timelines, and collaborated with cross-functional groups.
Prepare Technical Documentation: Given the importance of authoring and reviewing technical protocols and regulatory documents, mention your proficiency in drafting these types of documents. Highlight any experience you have with GMPs, ICH guidelines, and global regulatory requirements.
How to prepare for a job interview at Akebia Therapeutics
✨Showcase Your Technical Expertise
As a Principal Scientist, you'll need to demonstrate your deep understanding of drug product development. Be prepared to discuss your experience with pre-formulation characterization and process development in detail, highlighting specific projects where you made a significant impact.
✨Emphasise Leadership Skills
This role involves managing project teams and mentoring others. Share examples of how you've successfully led teams in the past, managed timelines, and navigated challenges. Highlight your ability to collaborate with cross-functional teams to achieve program goals.
✨Familiarise Yourself with Regulatory Requirements
Understanding GMPs, ICH guidelines, and global regulatory requirements is crucial. Prepare to discuss how you've supported regulatory submissions in previous roles and any experience you have with drafting technical documentation.
✨Prepare Questions for Your Interviewers
Interviews are a two-way street. Prepare insightful questions about the company's drug product strategies, team dynamics, and future projects. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
