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For Companies At a Glance
- Tasks: Lead drug product development and manage project teams in a dynamic environment.
- Company: Akebia is dedicated to improving lives affected by Chronic Kidney Disease through innovative therapeutics.
- 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.
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. 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 and biotech industries, especially those who have experience in drug product development. Attend industry conferences or seminars to meet potential colleagues and learn about the latest trends and technologies.
✨Tip Number 2
Familiarise yourself with Akebia's current projects and therapeutic areas, particularly in Chronic Kidney Disease. Understanding their mission and recent developments can help you tailor your conversations and demonstrate your genuine interest during interviews.
✨Tip Number 3
Prepare to discuss your leadership experiences and how you've successfully managed cross-functional teams in previous roles. Highlight specific examples where your strategic decisions led to successful project outcomes, as this aligns with the responsibilities of the Principal Scientist role.
✨Tip Number 4
Stay updated on regulatory guidelines and best practices in drug product development. Being knowledgeable about GMPs, ICH guidelines, and global regulatory requirements will not only boost your confidence but also show that you're well-prepared for the challenges of the role.
We think you need these skills to ace Principal Scientist, Drug Product Development
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in drug product development, particularly in small-molecule solid oral and parenteral drug development. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your strategic and technical leadership skills. Mention specific projects where you led teams or managed timelines and budgets, and explain how your experience aligns with Akebia's mission.
Highlight Relevant Qualifications: Clearly outline your educational background and any relevant certifications. Emphasise your 10+ years of experience and any specific expertise in pre-formulation characterization and process development.
Showcase Leadership and Collaboration Skills: In your application, provide examples of how you've successfully collaborated with cross-functional teams and mentored others. This will demonstrate your ability to lead and develop a team, which is crucial for this role.
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 requires strong leadership abilities. Share examples of how you've successfully managed project teams, timelines, and budgets in the past. Discuss your approach to mentoring and developing team members, as this will be crucial for the hiring managers.
✨Prepare for Regulatory Discussions
Given the importance of compliance and regulatory submissions in this position, brush up on your knowledge of GMPs, ICH guidelines, and global regulatory requirements. Be ready to discuss how you've navigated these areas in previous roles.
✨Demonstrate Collaborative Spirit
Collaboration is key in this role, so be prepared to talk about your experience working with cross-functional teams. Highlight instances where your collaboration led to successful outcomes, especially in supporting program goals and overseeing activities at contract manufacturing organisations.
