VP, Technical Operations
Akebia Therapeutics
August 26, 2026
Remote friendly (Waltham, MA)
United States
Operations
Summary
The Vice President, Technical Operations will lead end-to-end CMC Technical Operations strategy across Drug Substance, Drug Product, and CMC Program Management, advancing small-molecule products from candidate selection and IND-enabling development through clinical development, registration, validation, commercial launch, ongoing manufacturing, and lifecycle management.
Responsibilities
- Lead and develop Technical Operations and CMC Program Management; integrate/prioritize/execute Drug Substance, Drug Product, and cross-functional CMC activities across the product lifecycle.
- Develop and execute phase-appropriate CMC strategies (Drug Substance, Drug Product, analytical development, manufacturing, controls, stability, validation, regulatory CMC, supply) from IND-enabling through registration, commercialization, and post-approval lifecycle management.
- Provide technical leadership for small-molecule Drug Product development (formulation/process development, scale-up, technology transfer, characterization, control strategy, validation/PPQ, commercial readiness).
- Provide oversight for Drug Substance development/manufacturing (scale-up, technology transfer, validation, control strategy, commercial readiness, lifecycle support).
- Ensure CMC Program Management across the portfolio (deliverables, dependencies, critical paths, risks, resources, budgets, governance, decisions).
- Oversee CDMOs/external manufacturing partners for development, validation, and clinical/commercial manufacturing.
- Lead commercial manufacturing and lifecycle management (investigations, CAPAs, change controls, improvements, site transfers, continued process verification, supply continuity).
- Partner with Supply Chain, Regulatory Affairs, Quality, and Program leadership to meet FDA/ICH/global regulatory and cGMP expectations.
- Represent Technical Operations in cross-functional teams, executive governance, due diligence, portfolio planning, and risk management.
- Manage resources, operating plans, budgets, and portfolio priorities.
Qualifications
- MS/Ph.D. in Pharmaceutics/Pharmaceutical Sciences/Chemical Engineering/Chemistry (or related) with progressive pharmaceutical industry experience for a VP-level role.
- Extensive small-molecule development/manufacturing experience; deep Drug Product expertise (formulation/process development, scale-up, technology transfer, characterization, control strategy, validation/PPQ, regulatory approval, commercial launch, ongoing manufacturing), including leading PPQ/commercial validation at external sites.
- Broad Drug Substance technical knowledge to lead and challenge an experienced organization.
- Demonstrated end-to-end CMC strategy development and integration across Drug Substance, Drug Product, analytical, regulatory, quality, manufacturing, and supply.
- Strong CMC program/portfolio management (risks, dependencies, resources, budgets, timelines, governance, executive decision support).
- Significant CDMO/external manufacturing partner management experience.
- Strong cGMP and FDA/ICH/global regulatory knowledge; experience supporting INDs, NDAs, and post-approval submissions.
- Ability to lead multidisciplinary technical teams and influence senior stakeholders.
- Small-molecule Drug Product development across multiple dosage forms (oral solids and liquids).
- Commercial lifecycle management and global manufacturing network experience (post-approval changes, site transfers, optimization, supply risk, international submissions).
- Technical due diligence experience for licensing/acquisitions/partnerships.
Compensation and Benefits
- Targeted Base Salary: $291,349 USD - $359,902 USD.
- Additional benefits include health care, vision, dental, retirement, PTO, etc.
The Vice President, Technical Operations will lead end-to-end CMC Technical Operations strategy across Drug Substance, Drug Product, and CMC Program Management, advancing small-molecule products from candidate selection and IND-enabling development through clinical development, registration, validation, commercial launch, ongoing manufacturing, and lifecycle management.
Responsibilities
- Lead and develop Technical Operations and CMC Program Management; integrate/prioritize/execute Drug Substance, Drug Product, and cross-functional CMC activities across the product lifecycle.
- Develop and execute phase-appropriate CMC strategies (Drug Substance, Drug Product, analytical development, manufacturing, controls, stability, validation, regulatory CMC, supply) from IND-enabling through registration, commercialization, and post-approval lifecycle management.
- Provide technical leadership for small-molecule Drug Product development (formulation/process development, scale-up, technology transfer, characterization, control strategy, validation/PPQ, commercial readiness).
- Provide oversight for Drug Substance development/manufacturing (scale-up, technology transfer, validation, control strategy, commercial readiness, lifecycle support).
- Ensure CMC Program Management across the portfolio (deliverables, dependencies, critical paths, risks, resources, budgets, governance, decisions).
- Oversee CDMOs/external manufacturing partners for development, validation, and clinical/commercial manufacturing.
- Lead commercial manufacturing and lifecycle management (investigations, CAPAs, change controls, improvements, site transfers, continued process verification, supply continuity).
- Partner with Supply Chain, Regulatory Affairs, Quality, and Program leadership to meet FDA/ICH/global regulatory and cGMP expectations.
- Represent Technical Operations in cross-functional teams, executive governance, due diligence, portfolio planning, and risk management.
- Manage resources, operating plans, budgets, and portfolio priorities.
Qualifications
- MS/Ph.D. in Pharmaceutics/Pharmaceutical Sciences/Chemical Engineering/Chemistry (or related) with progressive pharmaceutical industry experience for a VP-level role.
- Extensive small-molecule development/manufacturing experience; deep Drug Product expertise (formulation/process development, scale-up, technology transfer, characterization, control strategy, validation/PPQ, regulatory approval, commercial launch, ongoing manufacturing), including leading PPQ/commercial validation at external sites.
- Broad Drug Substance technical knowledge to lead and challenge an experienced organization.
- Demonstrated end-to-end CMC strategy development and integration across Drug Substance, Drug Product, analytical, regulatory, quality, manufacturing, and supply.
- Strong CMC program/portfolio management (risks, dependencies, resources, budgets, timelines, governance, executive decision support).
- Significant CDMO/external manufacturing partner management experience.
- Strong cGMP and FDA/ICH/global regulatory knowledge; experience supporting INDs, NDAs, and post-approval submissions.
- Ability to lead multidisciplinary technical teams and influence senior stakeholders.
- Small-molecule Drug Product development across multiple dosage forms (oral solids and liquids).
- Commercial lifecycle management and global manufacturing network experience (post-approval changes, site transfers, optimization, supply risk, international submissions).
- Technical due diligence experience for licensing/acquisitions/partnerships.
Compensation and Benefits
- Targeted Base Salary: $291,349 USD - $359,902 USD.
- Additional benefits include health care, vision, dental, retirement, PTO, etc.