Senior Director, Technical Operations - Biologics

Akebia Therapeutics•Cambridge, MA

1d•Hybrid

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 The Senior Director, Technical Operations – Biologics, will lead the end-to-end CMC development and manufacturing strategy for AKB-097, ensuring successful progression from clinical development through commercialization. This CMC leader will be responsible for building and executing a comprehensive biologics manufacturing strategy, including process and analytical development, formulation development, external manufacturing, and regulatory CMC strategy. The Senior Director will serve as a key member of the Technical Operations leadership team and a strategic partner to R&D, Supply Chain, Quality, Regulatory, and Commercial leadership. This role will also oversee the external biologics manufacturing network, ensuring reliable clinical and commercial supply. The successful candidate will bring deep expertise in biologics product development and manufacturing and have experience advancing biologic products into late-stage development and commercialization. The individual will possess a proven ability to lead complex programs and teams in a dynamic biotechnology environment.

Requirements

MS or PhD in Biochemistry, Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline.
12+ years of progressive experience in biologics process development, product characterization, manufacturing, and technical operations within the biotechnology industry.
Demonstrated leadership advancing biologic therapeutics from development through late-stage clinical trials and commercialization.
Experience leading product comparability studies, supporting BLA submissions and commercial launch preparation.
Experience establishing and managing global biologics manufacturing networks.
Experience with monoclonal antibodies, recombinant proteins, or other complex biologics modalities.
Deep expertise in biologics CMC development, including cell culture and purification development, analytical development, formulation development, and manufacturing scale-up.
Strong knowledge of GMP requirements and global regulatory expectations for biologics.
Significant experience contributing to regulatory submissions (IND, BLA, or equivalent), including product comparability assessments.
Proven ability to lead complex development programs and organizations in a fast-paced biotechnology environment.
Strong strategic thinking, executive communication, and stakeholder management skills.
Demonstrated ability to build high-performing teams and external partnerships.

Responsibilities

Develop and execute the global CMC and manufacturing strategy for AKB-097, aligning technical development with regulatory and program objectives.
Serve as the CMC executive lead on the AKB-097 program team, representing Technical Operations in cross-functional decision making.
Establish long-term external manufacturing and lifecycle management strategies supporting global commercialization.
Provide technical and strategic oversight for drug substance and drug product process development, including cell line development, process development, formulation development, and manufacturing.
Oversee development of robust analytical methods, product characterization, including product comparability assessments.
Ensure successful scale-up, technology transfer, process validation, and commercial readiness.
Build and manage a network of CDMOs and strategic manufacturing partners supporting biologics development and manufacturing.
Lead governance structures and strategic partnerships with external manufacturers.
Ensure reliable clinical and commercial supply through effective planning, risk mitigation, and partnership with Akebia’s supply chain organization.
Provide leadership for CMC regulatory strategy supporting INDs, BLAs, and global regulatory filings.
Partner closely with Quality and Regulatory Affairs to ensure global compliance with GMP and regulatory requirements.
Support regulatory agency interactions, inspections, and CMC submission strategy.
Build and lead a high-performing biologics technical development and operations organization.
Recruit, develop, and mentor senior technical leaders and teams.
Foster a culture of scientific excellence, operational discipline, and continuous improvement.
Partner closely with Research, Clinical Development, Regulatory Affairs, Quality, Supply chain and Commercial teams to ensure integrated development and launch readiness.
Contribute to portfolio planning and corporate strategy discussions related to biologics development and manufacturing.