VP, Technical Operations: CMC Leader for Small Molecules

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

Benefits offered by this job

Health care

Vision/dental plans

Retirement plan

Paid time off (PTO)

Job summary

Akebia Therapeutics seeks a visionary VP, Technical Operations to lead end-to-end CMC operations across Drug Substance, Drug Product, and program management. The role drives IND-enabling development through lifecycle management, with emphasis on small-molecule formulation, process validation, technology transfer, and commercial readiness.

The ideal candidate will have deep Drug Product expertise, broad CMC leadership, and a track record of coordinating cross-functional teams, regulatory

Qualifications

• Extensive small-molecule development experience across Drug Product formulation, process development, and scale-up.
• Experience leading CDMO and external manufacturing partnerships.
• Strong regulatory knowledge for INDs, NDAs, and post-approval submissions.
• Proven ability to lead multidisciplinary technical teams and manage complex programs.

Responsibilities

• Lead and develop the Technical Operations and CMC Program Management organization across Drug Substance and Drug Product.
• Develop phase-appropriate CMC strategies from IND to post-approval lifecycle management.
• Provide oversight of Drug Substance development, scale-up, transfer, and commercial readiness.
• Ensure integration of regulatory, quality, manufacturing, and supply activities across programs.
• Oversee external manufacturing partners and ensure continuity of supply and quality.
• Collaborate with cross-functional partners to meet FDA and global regulatory expectations.

Skills

Small-molecule development

CDMO management

Regulatory submissions

Cross-functional leadership

Education

MS/PhD in Pharmaceutics or related

Job description

Akebia Therapeutics seeks a visionary VP, Technical Operations to lead end-to-end CMC operations across Drug Substance, Drug Product, and program management. The role drives IND-enabling development through lifecycle management, with emphasis on small-molecule formulation, process validation, technology transfer, and commercial readiness.

The ideal candidate will have deep Drug Product expertise, broad CMC leadership, and a track record of coordinating cross-functional teams, regulatory