Akebia Therapeutics · 8 hours ago
Principal Scientist, Drug Substance
Cambridge, MA
Full-time
Onsite
Senior Level, Lead/Staff
$153K/yr - $189K/yr
10+ years expAkebia Therapeutics is dedicated to improving the lives of those affected by Chronic Kidney Disease. The Principal Scientist of Drug Substance will provide technical leadership for late-stage product development and oversee the manufacturing process for praliciguat, ensuring compliance with regulatory requirements and timely delivery of drug substance supplies.
BiotechnologyHealth CareTherapeutics
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
Qualification
Required
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 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
Preferred
Experience with the use of statistical tools preferred
Benefits
Health care
Vision
Dental
Retirement
PTO
Company
Akebia Therapeutics
Akebia Therapeutics develops treatments for ischemia and vascular diseases.
201-500 employees
H1B Sponsorship
Akebia Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (5)
2023 (3)
2022 (12)
2021 (4)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$442.5M2024-01-30Post Ipo Debt· $37M
2020-05-11Post Ipo Equity· $151.8M
2019-11-12Post Ipo Debt· $100M
Leadership Team
John Butler
President and CEO
Erik Ostrowski
CBO & CFO
Recent News
2025-12-04
globallegalchronicle.com
2025-12-03
2025-12-02
Company data provided by crunchbase