Principal Scientist, Drug Product Development

CMC / Technical Operations

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?

Reporting to the SR Director, Drug Product as part the CMC Technical Operations team the Principal Scientist, Drug Product, will provide strategic and technical leadership within the CMC Technical Operations to support the development and optimization of Akebia's clinical and commercial programs. The incumbent will be accountable and responsible for pre-formulation process characterization, formulation development, manufacturing process development, identification of critical process parameters, process scale-up, technology transfers, and contract managed for all global drug product manufacturing sites. The Principal Scientist will directly support and be accountable for Akebia's pipeline of clinical and commercial programs to ensure timely delivery of clinical and commercial drug product inventory. The incumbent will support internal and external deviations/investigations, change controls, and authoring/review/approval of protocols, reports and relevant sections of clinical and commercial regulatory submissions (IND/IMPD, NDA/MAA) as well as the completion of commercial Annual Product Quality Reviews.

• Provide strategic, technical, and managerial leadership in the development and execution of drug product strategies for the development, optimization, scale-up, and manufacturing for Akebia's clinical and commercial programs.
• Lead project teams by providing oversight of project milestones, drive activities with additional project team members, manage timelines, contracts and invoices, and accountability for entire project.
• Collaborate with Akebia cross-functional teams to support overall program strategies, goals. and objectives
• Manage and oversee activities at contract organizations worldwide to assure compliant and robust manufacturing processes are both developed and/or maintained.
• Responsible and accountable for the timely production of clinical and commercial drug inventory to support Akebia clinical programs and supply for established commercial programs.
• Author, review and approve technical protocols and reports.
• Review and approval of commercial process validation related documentation including validation plans, manufacturing stage specific protocols, and validation reports.
• Employing the principles of Continuous Process Verification (CPV), evaluate and analyze manufacturing data through the use of statistical tools to develop process understanding, establishment of critical process parameters and in-process controls, and the identification of process improvements.
• Hire, mentor and develop a world class drug product organization by identifying experienced candidates and by providing coaching and feedback to all Drug Product personnel.
• Support regulatory submissions by writing/ reviewing/approving drug product related sections.
• Represent the Drug Product organization on program teams.

Required Qualifications:

• Bachelor's, Master's, or Ph.D. Degree in Organic Chemistry, Biochemistry, Chemical Engineering or a related discipline
• 10 years of relevant experience

Preferred Qualifications:

• Experience in pre-formulation characterization of drug substance strongly preferred
• Experience in developing phase appropriate formulations and drug process manufacturing processes.
• Experience in managing activities at contract development and manufacturing organizations.
• Experience in drafting protocols, technical reports and policies and procedures.
• Ability to review and approve clinical/commercial batch records and extract relevant data for analysis and trending.
• Experience in performing activities supporting registration and validation including but not limited to (preferred):
  • Identification and setting of critical process parameters and in process controls.
  • Identification of additional key process parameters to be monitored.
  • Writing/Reviewing/approving protocols and reports
  • Manufacturing Oversight
• Ability and desire to work in a fast-paced and dynamic environment.
• Knowledgeable in GMPs and relevant regulatory requirements.
• Demonstrated effective time management skills.
• Sound judgment and commitment to ethical conduct.
• Working knowledge of relevant ICH guidelines, GMPs and global regulatory requirements.
• Strong collaboration, team-building skills and communication skills

Compensation:

Targeted Base: $149,858 - $185,119*

*Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

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. Want to learn more about what it means to be an Akebian? Visit our website: www.akebia.com

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.