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
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
