Senior Manager Technical Operations

Kelly Science, Engineering, Technology & Telecom; Chicago (IL); On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading technology firm located in Chicago seeks a Senior Manager, Technical Operations to drive the transition of new products into manufacturing. This role involves leading a team of scientists and engineers, ensuring regulatory compliance, and managing technical support. The ideal candidate will have extensive experience in technical operations and design transfer in a regulated environment, particularly in the IVD or medical device fields.

Qualifications

• Ph.D. or Master's Degree in a Biomedical-related discipline (or Bachelor's with extensive experience).
• 5+ years in Technical Operations, Design Transfer, or Product Development.
• 5+ years of experience in a regulated environment following GMP (IVD, Medical Device, or Pharmaceutical fields).
• 2–3 years in a supervisory or management role.
• Strong expertise in molecular biology methods (PCR, qPCR, multiplex PCR, NGS).
• Proven experience leading molecular assay design transfer to manufacturing.

Responsibilities

• Lead the design transfer process to ensure products are manufacturable.
• Manage and develop a team of Process Scientists.
• Serve as the primary technical guide for existing products and processes.
• Direct and manage key strategic projects related to technology transfer.
• Ensure compliance with ISO and GMP requirements.
• Evaluate the technical capability of outsource providers.
• Develop new process formulas and technologies to achieve cost effectiveness.

Skills

Technical Operations

Design Transfer

Leadership

Regulatory Compliance

Molecular Biology Methods

Education

Ph.D. or Master's Degree in a Biomedical-related discipline

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)