Project Manager - CMO Relationship

LEX Diagnostics Limited; Royston; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A technology-driven diagnostics company based in Royston seeks a Project Manager to lead its CMO partnership, ensuring successful product transfer and launch. The ideal candidate will have proven experience in medical devices and excellence in stakeholder management. Responsibilities include managing relationships and overseeing cross-functional activities. The role offers a dynamic work environment with hybrid flexibility and robust employee benefits.

Benefits

Employer pension contribution of 10%

Private Medical Insurance

25 days annual holiday plus bank holidays

Discounts to local sports facilities and theater

Qualifications

• Proven experience managing relationships with Contract Manufacturing Organizations (CMOs).
• Experience in late stage product transfer to manufacturing.
• Willingness to travel frequently and work in a hybrid setting.

Responsibilities

• Manage day-to-day relationship with CMO partner.
• Drive late-stage transfer of medical device into production.
• Coordinate cross-functional activities between LEX and CMO.

Skills

Project management

Stakeholder management

People skills

Manufacturing processes knowledge

Regulatory compliance

Education

Experience in medical devices or diagnostics

Knowledge of ISO 13485 and FDA regulations

Job description

Social network you want to login/join with:

Project Manager - CMO Relationship, Royston

col-narrow-left

Client:

Location:

Royston, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

3c80c26d35e0

Job Views:

15

Posted:

11.08.2025

Expiry Date:

25.09.2025

col-wide

Job Description:

Looking to lead a partnership that shapes the future of diagnostics?
At LEX Diagnostics, we're rethinking what’s possible in diagnostics by making PCR results available in under 10 minutes, right at the point of care.

As we prepare to scale our game changing technology, we’re looking for a Project Manager who’s more than just organised. We need someone who can build a world class relationship with our Contract Manufacturing Organisation (CMO), drive late-stage product transfer into manufacturing, and help us successfully launch and scale in global markets.

What this role is all about:

You’ll be the bridge between LEX and our key manufacturing partner, a CMO based in the Northern Europe. Your job is to keep things running smoothly, influence without authority, and build such a strong partnership that the CMO wants to go the extra mile for you, because of you.

This role is essential to ensuring our device is manufactured to the highest standards, at scale, on time and ready for the demands of a global launch in 2026.

You’ll be responsible for:

• Managing the day-to-day relationship with our CMO partner
• Owning and driving the late-stage transfer of our medical device into full production
• Coordinating cross-functional activities between LEX and the CMO, from engineering to QA
• Monitoring timelines, risks, and deliverables to keep the manufacturing project on track
• Supporting future manufacturing scaleup and capacity planning ahead of our launch
• Acting as the primary communication channel between UK HQ and the CMO sites
• Travelling regularly to Norther Europe (and later to the USA) to maintain hands-on collaboration
• Being present in Cambridge regularly to stay connected with internal teams and leadership

Requirements

What we’re looking for:

• A seasoned project manager with proven experience in medical devices or diagnostics
• Strong track record in late stage product transfer to manufacturing
• A genuine relationship builder, people trust you, listen to you, and want to work with you
• Excellent stakeholder management, able to coordinate across internal and external teams
• Deep understanding of manufacturing processes, quality systems, and regulated product development
• Willingness and flexibility to travel frequently and work hybrid from our Cambridge site
• Previous experience managing CMO relationships in a regulated environment
• Knowledge of ISO 13485 and FDA regulated manufacturing
• Experience scaling production from pilot to commercial launch
• Exposure to both European and US based manufacturing and supply chains

Who are we and what does the future hold for you?

LEX Diagnostics was founded in 2020. Our innovative system integrates effortlessly into primary care settings, bringing PCR-level sensitivity to urgent care centres, physicians, labs, and pharmacies, all at a significantly lower cost per test than other molecular platforms.

2025 is a milestone year for us as we’ve just submitted dual 510(k) CLIA waiver applications to the U.S. FDA. This means you will be an important part of a high impact launch that will enhance your future career credentials.

The Future

In December 2023, QuidelOrtho invested in LEX Diagnostics, which included the exclusive option to acquire the company up to or shortly after 510(k) clearance by the FDA. In QuidelOrtho, we have an investment partner that recognises the capabilities of our team, and are excited for what we can continue to build together... We are optimistic to receive 510(k) clearance in late 2025 or early 2026.

What this means for you

1. More Resources - Manufacturing scale, regulatory & distribution infrastructure

2. R&D Focus - Concentrated innovation around LEX platform and test menu

3. Career Mobility - As well as creating a cross-disciplinary development environment in science and engineering, LEX employees can transition into broader roles (e.g., regulatory affairs, global supply chain, sales, clinical affairs) across the integrated organisation.

4. Global Exposure - International workflows & markets (US & EU)

5. Impact & Stability - Increased product reach and organisational strength

6. Development - Structured programs and training opportunities

2026 should see the elevation of the LEX Diagnostics team from startup environment into a well-supported, international diagnostics powerhouse without sacrificing the very thing that made our team successful, innovation. You’ll help drive forward a unique, market-leading platform within a growing team that needs to invest in your development and career growth.

Our working culture encourages entrepreneurship, shared ideas, and technical collaboration, while providing you the freedom to do your best work. We also offer fantastic employee benefits including:

· Employer pension contribution of 10% (+3% personal contribution)

· Private Medical Insurance

· 25 days’ annual holiday plus bank holidays

· Discounts and memberships to local sports facilities and the theatre

Ready to lead a critical partnership and bring a breakthrough product to life?

Apply now and help us manufacture diagnostics that matter, at speed, at scale, and at the point of care.