Senior Director, Drug Substance Development

4 weeks ago

Cambridge, Massachusetts, United States Akebia Therapeutics Full time
Job Summary

Akebia Therapeutics is seeking a Senior Director, Drug Substance to provide operational and strategic leadership to the Drug Substance organization within Technical Operations. The successful candidate will be responsible for developing and optimizing Akebia's clinical and commercial programs, ensuring timely delivery of clinical and commercial drug substance inventory.

Key Responsibilities
  • Provide strategic, technical, and managerial leadership related to drug substance 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's Medicinal Chemistry group to support route scouting of research compounds, identify pre-Phase 1 process development/optimization opportunities, identification and determination of known and potential process impurities, and support the manufacturing of material to be utilized in GLP toxicology studies.
  • 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 substance organization by identifying experienced candidates and by providing coaching and feedback to all Drug substance personnel.
  • Support regulatory submissions by writing/reviewing/approving drug substance related sections.
  • Represent the Drug Substance organization on program teams.
Requirements
  • Bachelor's, Master's, or Ph.D. Degree in Pharmaceutical Sciences, Organic Chemistry, Biochemistry, Chemical Engineering or a related scientific discipline.
  • 15+ years of relevant industry experience with at least 5 years in a leadership position.
  • Extensive knowledge and experience in the development and manufacture of small molecules.
  • Strong problem-solving ability utilizing experience and data analysis to quickly drive scientifically sound decisions and solve development and manufacturing issues quickly.
  • Well-developed knowledge of relevant ICH guidelines, GMPs and global regulatory requirements.
  • Experience through all stages of the development lifecycle (Phase 1 through Validation), including leading commercial manufacturing oversight at contract manufacturing organizations.
  • Demonstrated acumen and program success with respect to phase appropriate chemical synthetic manufacturing processes supporting clinical and commercial programs.
  • Experience in managing activities at contract development and manufacturing organizations.
  • Ability to critically review and approve development and commercial documents (protocols, reports, batch records, regulatory filings) and extract relevant data for analysis and trending.
  • Experience in supporting global regulatory filings (IND, NDA, CTA, IMPD, MAA, etc.).
  • Up to 25% of time for international and domestic travel may be required.
  • 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.
  • Strong collaboration, team building and communication skills.

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