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)