Director Commercial Technical Operations

Job Title

Director, Commercial Technical Operations

Requisition

JR000016048 Director, Commercial Technical Operations (Open)

Location

College Park, Dublin

Additional Locations

Job Description Summary

The Director, Commercial Technical Operations is responsible for leading the commercial product technical stewardship, manufacturing support, lifecycle management, technology transfer, manufacturing network development, and continuity-of-supply capabilities within Technical Operations. The role serves as the accountable leader for the Commercial Technical Operations function.

The position provides strategic technical leadership across commercial drug substance and drug product manufacturing operations, external manufacturing networks, technology transfers, lifecycle changes, manufacturing resilience initiatives, and portfolio stewardship activities. The role acts as a key technical integration point between Technical Operations, Supply Chain, Quality, Regulatory Affairs, Manufacturing Operations, and external manufacturing partners.

The role is expected to support development of the future-state Commercial Technical Operations organization, build organizational capability, develop future leadership talent, and ensure a successful transition from the current operating model to a scalable Technical Operations capability.

Job Description

Essential Functions

·       Lead the Commercial Technical Operations function and establish the future-state operating model.

·       Provide portfolio-level technical leadership across product stewardship, manufacturing support, lifecycle management, technology transfer, manufacturing-network development, and continuity-of-supply programs.

·       Maintain accountability for technical governance of commercial manufacturing operations, lifecycle execution, manufacturing investigations, manufacturing-network expansion, and manufacturing resilience initiatives.

·       Oversee technology transfers, CMO technical assessment, site onboarding, manufacturing readiness, startup support, and capacity expansion programs.

·       Ensure effective partnership with all other technical operations subfunctions, Quality, Regulatory Affairs, Supply Chain, and Operations.

·       Develop organizational capability, succession planning, talent pipelines, and scalable resource models supporting future business needs.

·       Provide executive visibility of product health, manufacturing risks, lifecycle portfolios, technology-transfer activities, and strategic manufacturing initiatives.

·       Serve as a member of the Technical Operations leadership team and contribute to the long-term strategic development of the function.

Minimum Requirements

Education / Experience / Skills:

·       Bachelor's degree in engineering, pharmaceutical sciences, biotechnology, chemistry, or related technical discipline required; advanced scientific or engineering degree preferred.

·       Minimum 10 years of experience supporting pharmaceutical or biopharmaceutical manufacturing operations within regulated GMP environments.

·       Significant experience in manufacturing support, technology transfer, product stewardship, lifecycle management, process validation, and manufacturing investigations.

·       Demonstrated leadership experience in Technical Operations, Manufacturing Science & Technology, Process Development, Manufacturing Support, and related functions.

·       Experience managing external manufacturing organizations, strategic suppliers, technology transfer programmes, and manufacturing network expansion initiatives.

·       Strong understanding of lifecycle management, change management, process validation, manufacturing controls, and pharmaceutical quality systems.

·       Working knowledge of FDA, EU GMP, ICH, combination product, and applicable pharmaceutical manufacturing regulations.

·       Proven ability to lead cross-functional initiatives and influence decision making across complex matrix organizations.

·       Strong strategic planning, organizational leadership, communication, and stakeholder-management capabilities.

·       Demonstrated experience developing technical organizations, leading organizational change initiatives, and building future-state capabilities.

Organizational Relationship/Scope:

The Director, Commercial Technical Operations reports directly to the Vice President of Technical Operations.

The role is accountable for Manufacturing Science & Technology and provides leadership across manufacturing support, product stewardship, lifecycle management, technology transfer, manufacturing network development, continuity-of-supply programs, and associated technical operations activities. The position is expected to manage a combination of direct reports, specialist technical resources, and matrix teams supporting strategic manufacturing initiatives.

The role works extensively with all other Technical Operations Sub Functions, Supply Chain, Regulatory Affairs, Quality, Operations, Commercial, Business Development, and external manufacturing organizations. The position serves as one of the primary leadership roles within the future-state Technical Operations operating model.

Working Conditions:

This position is a hybrid role based in Dublin, Ireland and requires a minimum on-site presence of three (3) days per week. Work is performed in both office and pharmaceutical manufacturing environments, including cleanrooms, laboratories, packaging, warehousing, and other GMP-regulated areas. Travel is required to Internal and External manufacturing organizations (CMOs) and partner sites, and other domestic or international locations as business needs dictate.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.