Principal Scientist, Drug Substance

Akebia Therapeutics•Cambridge, MA

About The Position

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? Job Summary Reporting to the Sr. Director, Drug Substance, the Principal Scientist of Drug Substance will primarily provide technical leadership for late-stage product development, process optimization, and manufacturing to support Phase 3 and registration activities for Akebia’s praliciguat program. The Principal Scientist will be responsible for the identification of critical process parameters, process scale-up and technical transfers, and the oversight of contract drug substance manufacturing sites relating to the program. The Principal Scientist will ensure timely delivery of drug substance supplies for research, non-clinical and clinical activities, provide support to internal and external deviation/investigation, change controls, and authoring and/or review of protocols, reports and relevant sections of IND/IMPD and NDA/MAA

Requirements

Bachelor’s, Master’s, or Ph.D. Degree in Organic Chemistry, Biochemistry, Chemical Engineering or a related discipline
10+ years of relevant experience
Experience in small molecule chemical process development, technology transfer and oversight of activities at external partners.
Direct experience in managing activities at contract development and manufacturing organizations.
Advanced writing skills required. Includes the ability to draft protocols, technical reports, impact assessments, process justification reports, policies and procedures.
Ability to review and approve clinical/commercial batch records and extract relevant data for analysis and trending.
Experience with review and approval of commercial process validation related documentation: validation plan, manufacturing stage specific protocols, validation reports.
Experience with the use of statistical tools preferred.
Experience in performing activities supporting registration and validation including but not limited to: Impurities fate/purge assessments. 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, start-up environment.
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 required.

Responsibilities

Provide technical and tactical leadership for the phase-appropriate execution of drug substance strategies to support the development, optimization, scale-up, and manufacturing of praliciguat drug substance.
Lead Praliciguat CMC drug substance Project Team.
Provide oversight of project milestones, drive activities with additional project team members, as required, manage timelines, contracts, invoices and be both responsible and accountable for project deliverables.
Assist functional and senior CMC leadership to develop risk-based strategies with respect to process development and commercial activities that include but are not limited to route scouting, registration, validation and clinical/commercial manufacturing.
Assist in the identification and characterization of process impurities. Provide the technical rationale for impurity structures and routes of formation.
Author/review and approve technical protocols, reports, and batch records.
Oversee and manage activities at contract manufacturing organizations (CMOs); ensure timely production of drug substance inventory, ensuring robust compliance with Akebia processes, procedures, and regulatory requirements.
Use statistical tools to develop process understanding, analyze data to establish critical process parameters and in-process controls, and identify process improvements.
Foster a collaborative team environment that contributes to cross-functional problem solving and decision-making.
Support regulatory submissions by writing and reviewing drug substance-related sections.
Up to 25% of time allocated to domestic travel, as required. Some international travel may be required.