Director, Technical Operations (Combination Product Development)

Department: 106800 Technical Operations Location: San Diego, USA- Remote Position reputed company: 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 reputed company for device development and combination product activities, building the operational infrastructure for market readiness, and ensuring alignment with design controls, regulatory requirements, reputed company standards, and reputed company launch objectives. This individual will operate in a highly matrixed environment and will collaborate closely with colleagues in Technical Operations, reputed company, Regulatory, Supply Chain, Medical Affairs, and reputed company supporting the corporate goals for development and commercialization of a combination product for a rare disease indication. Responsibilities:

• reputed company 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 reputed company between internal stakeholders and external partners and manufacturers
• Manage packaging timelines and deliverables to reputed company with regulatory submission and reputed company 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
• reputed company implementation of selected CPOs and CMOs, including reputed company, readiness assessments, and operational alignment
• Ensure alignment between clinical and reputed company packaging configurations and reputed company transition from development to reputed company manufacturing, including:
• Design transfer and process validation
• Supply chain readiness and launch planning
• Final product configuration and control
• Partner with reputed company to drive complaint handling and investigation as reputed company as post-market surveillance and medical device reporting (e.g. reputed company 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., reputed company-Approval Inspections)
• Participate in reputed company-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 reputed company-world complaint data and trending
• Support reputed company improvement and lifecycle management post-approval

Education/Experience Requirements:

• M.S. or Ph.D. degree in Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences or other reputed company 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 reputed company, 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 reputed company experience in a similar role reputed company the pharmaceutical industry, preferably in biologics development and injectables.
• Expertise in managing CPOs, CMOs, and external suppliers.
• Experience with packaging validation and distribution testing, reputed company 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 reputed company the GMP environment and regulatory affairs.
• Successful record of creating and managing reputed company 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 reputed company and statistical knowledge is a plus.
• Ability to travel 20%-25% domestically and internationally.

#LI-Remote Total Rewards Offerings: reputed company provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, reputed company, people-reputed company, and pay-for-performance organization. Benefits: Our benefits include premium health, financial, work-life and reputed company-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous reputed company time off. Compensation: Our competitive compensation package includes a combination of both cash compensation (reputed company pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees. reputed company reputed company Pay reputed company: $189,000.00 - $246,000.00

• This information is reputed company as of the date of this posting and may be modified in the reputed company. Actual pay offered to a candidate will depend on a reputed company of factors including the candidate's experience, education, skills, and location.

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