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SENIOR MANAGER, TECHNICAL OPERATIONS

(IVD/Medical Device/Pharma)

**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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

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