VP, Technical Operations — CMC Strategy & Manufacturing

Akebia Therapeutics; Waltham (MA); Hybrid; USD 291,000 - 360,000; Full time

Benefits offered by this job

Health care

Vision/dental coverage

Retirement plan

PTO

Job summary

Akebia Therapeutics is seeking a Vice President of Technical Operations to lead end-to-end CMC operations for drug substance, drug product, and program management. This role requires deep small-molecule Drug Product experience, strategic oversight, and strong collaboration across clinical and commercial programs.

The candidate will drive scalable manufacturing, technology transfer, validation campaigns, and regulatory readiness, partnering with Supply Chain, Regulatory Affairs, and Quality to

Qualifications

• Advanced degree and substantial pharmaceutical industry experience suitable for a VP-level role.
• Extensive small-molecule development and manufacturing experience across Drug Product formulation, process development, scale-up, and regulatory readiness.
• Proven ability to lead end-to-end CMC development strategies and integrate cross-functional activities across R&D, regulatory, quality, and supply.

Responsibilities

• Lead Technical Operations and CMC Program Management across Drug Substance, Drug Product, and portfolio.
• Develop phase-appropriate CMC strategies spanning development, validation, regulatory submissions, and lifecycle management.
• Provide strategic and technical oversight of Drug Substance development and manufacturing, including scale-up and tech transfers.
• Oversee CDMOs and external partners involved in development, validation, and manufacturing.
• Ensure alignment with FDA/ICH/global regulatory expectations and supply continuity across programs.

Skills

Leadership

Strategic thinking

Cross-functional collaboration

Communication

Influencing stakeholders

Education

MS/PhD in Pharmaceutics/Pharmaceutical Sciences/ Chemical Engineering/ Chemistry

Tools

PPQ & regulatory validation campaigns

Technology transfer

External manufacturing oversight

Job description

Akebia Therapeutics is seeking a Vice President of Technical Operations to lead end-to-end CMC operations for drug substance, drug product, and program management. This role requires deep small-molecule Drug Product experience, strategic oversight, and strong collaboration across clinical and commercial programs.

The candidate will drive scalable manufacturing, technology transfer, validation campaigns, and regulatory readiness, partnering with Supply Chain, Regulatory Affairs, and Quality to