Job Description

Our client is seeking a Manager, Combination Product Development and Manufacturing to support the development, technology transfer, and manufacturing of device-combination drug products at contract manufacturing organizations (CMOs). A key component of this role is supporting the manufacturing of commercial combination products as well as providing technical expertise for additional development and supply-chain expansion efforts. This is a remote position with approximately 25% travel.

Responsibilities

• Support activities for commercial manufacturing of device combination drug products at CMOs, including technical review of drug product batch records, on-site “person-in-plant” technical oversight, and support of other manufacturing activities at CMOs as required.
• Collaborate within Tech Ops and internal project teams including Supply Chain, Quality Control, Quality Management, and Regulatory Affairs, as required, for timely execution of combination product manufacturing activities.
• Provide engineering and technical knowledge to support injection molding, valve actuator assemblies, metering mechanisms, dimensional tolerances and functional performance, spray pattern, and aerodynamic particle size distribution (APSD).
• Maintain technical documentation of device history (DHF), process validation, and commercial manufacturing, and support combination device regulatory filings.
• Collect, analyze, and summarize data for continuous process verification (CPV) and provide input into remediation plans for identified gaps.
• Support combination product / device-related technical activities, including coordination with device suppliers/partners on components, specifications, and technical issue resolution.
• Partner with Quality and Regulatory to help ensure device/combination-product documentation expectations are met (e.g., device master record/device history record inputs where applicable) and support inspection readiness.
• Ensure manufacturing changes and investigations consider combination-product requirements, including interface with design controls and risk management activities as applicable.
• Create and review technical documents, reports, updates, and presentations for cross-functional teams and management.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Engineering, Chemistry, or a closely related field.
• A minimum of 4 years of experience with development and commercialization of device combination drug products.
• Drug-device combination product experience required, including familiarity with applicable device quality system requirements (e.g., 21 CFR Part 820/4 and ISO 13485) and risk management principles (e.g., ISO 14971) as applicable.
• Experience in GMP device manufacturing in the pharmaceutical industry, in a research and development, process development, manufacturing, or contract manufacturing role.
• Experience with human factors and use error engineering, dose accuracy and delivery performance, container closure systems, and extractables/leachables.
• Solid background in device combination development, technology transfer of manufacturing processes, and troubleshooting and process improvements, including experience supporting combination products and device-component interfaces.
• Experience working with contract manufacturers.
• Hands-on experience with quality systems in a regulated environment, including change control, risk management, CAPA, and deviations; working knowledge of SOPs and ICH guidelines.
• Experience working in a multi-cultural, multi-lingual environment, with a demonstrated ability to contribute successfully to a multi-disciplinary team.
• Ability to work in a dynamic group that takes a multi-disciplinary team approach to achieving departmental and corporate goals.
• Experience in statistical analysis, interpretation, and summary (control charts) of trending data is a plus.
• Self-motivated, organized, reliable, and responsive.
• Proficient with office and applicable business systems, including Trackwise, Veeva, and similar platforms.
• Domestic and international travel required (up to 25%).

Location

• Remote

Employee Type

• Direct Hire

Compensation & Benefits

• Base salary: $138,000 - $176,000
• Eligible for performance-based bonus program
• 401(k) matching plan
• Health insurance
• Paid time off and holidays

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

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