Director, Technical Operations (combination Product Development) - Remote Eligible

Director, Technical Operations (Combination Product Development)

Position Summary: The Director of Technical Operations (Combination Product Development) is responsible for leading device development of a combination product program from late-stage development (Phase 3) through regulatory approval, global commercialization, and lifecycle management. This role serves as the technical lead for device development and combination product activities, building the operational infrastructure for market readiness, and ensuring alignment with design controls, regulatory requirements, quality standards, and commercial launch objectives. This individual will operate in a highly matrixed environment and will collaborate closely with colleagues in Technical Operations, Quality, Regulatory, Supply Chain, Medical Affairs, and Commercial supporting the corporate goals for development and commercialization of a combination product for a rare disease indication.

Responsibilities:

• Lead the device program from Phase 3 through regulatory approval, commercialization, and lifecycle management
• Drive execution against key milestones including design verification and qualification, process validation (PPQ), BLA submission, and launch readiness
• Serve as the primary technical liaison between internal stakeholders and external partners and manufacturers
• Manage packaging timelines and deliverables to align with regulatory submission and commercial launch milestones; and ensure supply chain and external partners readiness for product launch
• Assess external partners such as Contract Packaging Organizations (CPOs) and Contract Manufacturing Organizations (CMOs) based on technical capability, regulatory compliance, operational readiness, scalability, and cost effectiveness
• Oversee implementation of selected CPOs and CMOs, including onboarding, readiness assessments, and operational alignment
• Ensure alignment between clinical and commercial packaging configurations and lead transition from development to commercial manufacturing, including: Design transfer and process validation Supply chain readiness and launch planning Final product configuration and control
• Partner with Quality to drive complaint handling and investigation as well as post-market surveillance and medical device reporting (e.g. root cause analysis, device malfunction and safety)
• Author and/or review global regulatory submissions for combination product (e.g., BLA with device constituent) and ensure regulatory inspections readiness (e.g., Pre-Approval Inspections)
• Participate in Pre-Approval Inspections and routine audits as device SME
• Support contract negotiations by providing technical input on scope, capabilities, and operational feasibility
• Drive integrated risk management across drug-device interfaces; continuously update the Post-Market Risk Management file (ISO 14971) based on real-world complaint data and trending
• Support continuous improvement and lifecycle management post-approval

Education/Experience Requirements: M.S. or Ph.D. degree in Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences or other related disciplines. Equivalent combination of education and applicable job experience may be considered. Minimum 8 years of relevant experience in device development and commercialization of a combination product. Strong knowledge of combination product regulatory framework, drug development (CMC), and device development including design controls, risk management, verification/validation, and design transfer.

Additional Skills/Experience: Experience with BLA submissions including device constituent components is required. Strong professional experience in a similar role within the pharmaceutical industry, preferably in biologics development and injectables. Expertise in managing CPOs, CMOs, and external suppliers. Experience with packaging validation and distribution testing, human factors/usability engineering. Background in device engineering or systems engineering is a plus. Strong project management experience, PMP certification is preferred. Prior experience interacting with FDA or other regulatory agencies. Broad knowledge and experience within the GMP environment and regulatory affairs. Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies. Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes. Strong interpersonal and organizational skills and excellent verbal and written communication skills are required. Excellent decision-making and collaboration skills with strong attention to detail. Six Sigma and statistical knowledge is a plus. Ability to travel 20%-25% domestically and internationally.