VP, Technical Operations

Summary

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?

Responsibilities

• Lead and develop the Technical Operations and CMC Program Management organization, ensuring effective integration, prioritization, and execution of Drug Substance, Drug Product, and cross-functional CMC activities across the product lifecycle.
• Develop and execute integrated, phase-appropriate CMC strategies spanning Drug Substance, Drug Product, analytical development, manufacturing, controls, stability, validation, regulatory CMC, and supply, from IND-enabling development through registration, commercialization, and post-approval lifecycle management.
• Provide deep technical leadership for small-molecule Drug Product development, including formulation/process development, scale-up, technology transfer, process characterization, control strategy, validation/PPQ, and commercial readiness.
• Provide strategic and technical oversight of Drug Substance development and manufacturing, including scale-up, technology transfer, validation, control strategy, commercial readiness, and lifecycle support.
• Ensure effective CMC Program Management across the portfolio, integrating deliverables, dependencies, critical paths, risks, resources, budgets, governance, and key decisions.
• Oversee CDMOs and external manufacturing partners supporting Drug Substance and Drug Product development, validation, and clinical/commercial manufacturing.
• Provide senior technical leadership for ongoing commercial manufacturing and lifecycle management, including investigations, CAPAs, change controls, process improvements, site transfers, continued process verification, and supply continuity.
• Partner with Supply Chain, Regulatory Affairs, Quality and Program leadership to ensure CMC strategies and submissions meet applicable FDA, ICH, global regulatory, and cGMP expectations.
• Represent Technical Operations in cross-functional product teams, executive governance, Business Development due diligence, portfolio planning, and risk management.
• Manage Technical Operations resources, operating plans, budgets, and portfolio priorities to support corporate and product development objectives.

Qualifications

• MS/Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related discipline, with substantial progressive pharmaceutical industry experience appropriate for a Vice President-level role.
• Extensive small-molecule pharmaceutical development and manufacturing experience, with deep Drug Product expertise spanning formulation/process development, scale-up, technology transfer, process characterization, control strategy, validation/PPQ, regulatory approval, commercial launch, and ongoing commercial manufacturing, including experience leading PPQ and commercial validation campaigns at external manufacturing sites.
• Broad technical knowledge of Drug Substance development and manufacturing sufficient to lead and challenge an experienced Drug Substance organization.
• Demonstrated ability to develop and execute end-to-end CMC development strategies and integrate Drug Substance, Drug Product, analytical, regulatory, quality, manufacturing, and supply activities.
• Significant experience managing CDMOs/external manufacturing partners across development, technology transfer, validation, and clinical/commercial production.
• Strong knowledge of cGMP and CMC-relevant FDA, ICH, and global regulatory expectations, with experience supporting INDs, NDAs, and post-approval submissions.
• Proven ability to lead multidisciplinary technical teams, influence senior stakeholders, and resolve complex technical and business challenges.
• Experience with small-molecule Drug Product development across multiple dosage forms, including oral solid dosage forms (tablets and/or capsules) and liquid formulations.
• Experience with commercial product lifecycle management and global manufacturing networks, including post-approval changes, site transfers, process optimization, supply risk management, and international regulatory submissions.
• Experience with technical due diligence for licensing, acquisitions, partnerships, or new portfolio assets.