Senior Manager, Technical Operations

Senior Manager, Technical Operations

Location: Northbrook, IL

Target Salary: $150,000 - $200,000 (Base) + 20% Bonus

Relocation: Assistance Provided

Position Summary:

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

Required Education/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.

For immediate consideration, please forward your updated resume.