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Job description
Senior Manager, Technical Operations (IVD/Medical Device/Pharma)
Location: Suburb of north Downtown Chicago
Pay Range: $150,000.00/yr - $200,000.00/yr
Relocation: Assistance Provided
The Senior Manager, Technical Operations is a pivotal technical leadership responsible for driving the successful transition of new products into manufacturing and providing comprehensive on-market support. This leader will hire, manage, develop, and mentor a high-performing team of scientists and engineers, focusing on Design Transfer, Design for Manufacturability, Process Validation, and Continuous Improvement.
Key Responsibilities
Design Transfer & Process Robustness: Lead the design transfer process to ensure products are manufacturable (Design for Manufacturability) and scalable. Provide scientific and technical expertise to manufacturing operations.
Team Leadership & Mentorship: Manage and develop a team of Process Scientists, fostering a customer-centric and engaged culture. Actively support and engage in laboratory-based troubleshooting and key focus areas.
Technical Support & Troubleshooting: Serve as the primary technical guide for existing products and processes. Resolve complex technical issues, manage investigations into field complaints/recalls, and initiate process improvements for quality, delivery, and cost.
Project Management: Direct and manage key strategic projects (internal and external) related to technology transfer, process development, optimization, and validation, ensuring all milestones are met.
Regulatory Compliance: Ensure all operations, procedures, and documentation comply with ISO 9001, ISO 13485, FDA, and GMP/CMD/CAS requirements. Assist Quality/Regulatory teams with internal and external audits.
Strategic Outsourcing & Cost: Evaluate the technical capability of outsource providers, analyze data to determine insourcing/outsourcing decisions, and monitor/control labor and capital expenditures.
Innovation: Develop and recommend new process formulas and technologies to achieve cost effectiveness and improve product quality.
Qualifications & Experience
Education: Ph.D. or Master's Degree in a Biomedical-related discipline (or Bachelor's with extensive experience).
Technical Experience: 5+ years in Technical Operations, Design Transfer, or Product Development.
Regulated Environment: 5+ years of experience in a regulated environment following GMP (IVD, Medical Device, or Pharmaceutical fields).
Leadership: 2–3 years in a supervisory or management role.
Assay Expertise: Strong expertise in molecular biology methods (PCR, qPCR, multiplex PCR, NGS).
Key Focus: Proven experience leading molecular assay design transfer to manufacturing.
Benefits
Medical insurance
Vision insurance
401(k)
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Worksite address
chicago, IL, 60290, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.