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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.
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 at www.akebia.com . Akebia is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. #J-18808-Ljbffr
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
Familiarise yourself with the latest trends in drug product development, especially in chronic kidney disease. This knowledge will not only help you during interviews but also demonstrate your genuine interest in the field.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, particularly those who have experience in CMC Technical Operations. Attend relevant conferences or webinars to make connections that could lead to valuable insights and recommendations.
✨Tip Number 3
Prepare to discuss specific examples of your leadership and project management experiences. Highlight how you've successfully managed timelines, budgets, and cross-functional teams in previous roles to align with the responsibilities of the Principal Scientist position.
✨Tip Number 4
Research Akebia's recent projects and initiatives related to drug product development. Being able to reference their work during your discussions will show that you're proactive and genuinely interested in contributing to their mission.
We think you need these skills to ace Principal Scientist, Drug Product Development
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Principal Scientist position at Akebia. Make sure to understand the key responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise your 10+ years of relevant experience in drug development, 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 highlight any leadership roles you've held. Discuss your experience in managing timelines, contracts, and budgets, as well as your ability to collaborate with cross-functional teams.
Prepare Technical Documentation: Given the importance of authoring and reviewing technical protocols and regulatory documents, include examples of your experience in drafting such materials. Mention your familiarity with GMPs, ICH guidelines, and global regulatory requirements to strengthen your application.
How to prepare for a job interview at Akebia Therapeutics
✨Understand the Role Thoroughly
Before your interview, make sure you have a solid grasp of the Principal Scientist position and its responsibilities. Familiarise yourself with drug product development processes, especially in relation to chronic kidney disease, as this will show your genuine interest in the role.
✨Prepare for Technical Questions
Given the technical nature of the role, be ready to discuss your experience with pre-formulation characterization, formulation development, and process scale-up. Brush up on relevant regulations and guidelines like GMPs and ICH to demonstrate your expertise.
✨Showcase Leadership Skills
As a Principal Scientist, you'll need strong leadership abilities. Be prepared to share examples of how you've successfully managed project teams, timelines, and budgets in the past. Highlight any mentoring experiences to illustrate your capability in developing others.
✨Ask Insightful Questions
At the end of the interview, take the opportunity to ask thoughtful questions about the company's drug product strategies and team dynamics. This not only shows your enthusiasm but also helps you gauge if the company culture aligns with your values.
