Principal Scientist, Drug Product Development

1 week ago

Cambridge, Massachusetts, United States Akebia Therapeutics Full time
Job Title: Principal Scientist, Drug Product Development

Akebia Therapeutics is seeking a highly skilled Principal Scientist to join our CMC Technical Operations team. As a key member of our team, you will provide strategic and technical leadership in the development and execution of drug product strategies for our clinical and commercial programs.

Key Responsibilities:
  • 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.
Requirements:
  • 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.

Akebia Therapeutics 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.

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