Head of Platform Engineering

cTRL Therapeutics is redefining cell therapy for solid tumors through its proprietary Iso Qore™ platform, which isolates and expands circulating tumor‑reactive lymphocytes (cTRLs) from peripheral blood. The company’s lead product, cTRL‑001, offers a scalable and outpatient‑ready solution for a broad range of solid tumors. cTRL is advancing its clinical pipeline to enhance patient access to life‑saving therapies. For more information, please visit  .

Location:

Chicago

What you’ll do:

We are seeking a highly motivated and experienced candidate to oversee Iso Qore platform development, optimization and scaling of our platform for clinical manufacturing and our overall business development efforts. You will lead our plan to develop a set of collaborators and partners for ongoing advancement of future iterations of our Iso Qore platform and consumables. You will collaborate with internal and external team members and partners as we execute on various research, IND and clinical development milestones to build and advance our pipeline of cTRL therapeutics.

You will be a member of our leadership team that will deliver on our corporate objectives. Importantly, you will be the most senior full‑time leader based in Chicago and therefore, be the “site lead” and will be responsible for maintaining and building the culture at our Portal Innovations Chicago location. You will lead a small group of direct and indirect team members.

Reporting line:
Reports to the CEO, with dotted line to our Founder/CTO

Key Responsibilities:

Strategic Leadership & Business Development

Lead and manage cross‑functional engineering team in the design, development, and commercialization of Iso Qore platform

Develop and implement engineering strategies aligned with company goals and product roadmaps

Provide technical leadership in the innovation and optimization of Iso Qore V. 1.0

Develop and execute on a partnering strategy to likely include one or more collaborators over time

Oversee all stages of product development, from concept design to regulatory approval and potential commercialization

Ensure platform meet technical, functional, safety, and regulatory requirements

Foster innovation by identifying emerging trends, new technologies, and opportunities for product improvement

Regulatory & Compliance Oversight

Ensure compliance with medical device regulations (e.g., FDA, ISO, CE Mark) throughout the development process

Interface with regulatory bodies during audits, submissions, and reviews to ensure product safety and compliance

Oversee risk management activities, including hazard analysis, FMEAs (Failure Modes and Effects Analysis), and risk assessments.

Team Management & Development

Recruit, mentor, and develop engineering talent, fostering a culture of collaboration and innovation

Set performance goals, conduct reviews, and provide guidance to ensure team members are meeting expectations

Build and maintain a collaborative relationship with cross‑functional teams (R&D, manufacturing, regulatory affairs)

Project Management

Lead multiple engineering projects, ensuring they are completed on time, within scope, and within budget

Manage resource allocation, timelines, and deliverables for engineering projects

Collaborate with stakeholders across departments to ensure alignment and execution

Budget & Resource Management

Develop and manage budgets, ensuring effective use of resources and cost efficiency

Evaluate and seek approval for investments in new technologies, equipment, and partnerships to drive innovation and efficiency

Quality & Process Improvement

Implement best practices in design controls, quality management systems, and continuous improvement processes

Ensure high‑quality standards are maintained throughout product development and production

You should have:

Bachelor’s or master’s degree in engineering (Biomedical, Mechanical, or related field). An M.B.A. or Ph.D. is a plus

At least, 15 years of experience in medical device or instrument development, with at least 5 years in a leadership role

Basic understanding of engineering and instrument design and manufacturing techniques

In‑depth knowledge of FDA regulations, ISO standards, and other global…