Laboratory Operations Supervisor
5 months ago
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
As one of the largest Clinical Research Organizations in the world, we have recently brought to life four ultramodern Clinical Research Units in the UK and USand the jewel in the crown is our facility at Drapers Yard Leeds. A brand new, world class, state-of-the-art 65,000 ft² clinic with 100 beds (and growing), fully dedicated to Phase I Clinical research (and 7 minutes walking from the train station)
And this is where you come in because the laboratory in the Clinic is expanding and is now seeking our next Clinical Operations Laboratory Supervisor.
- This is an office-based, full-time and permanent opportunity, working hours are 37 hours per week, five days over seven
- You will be required to work a mix of shifts, including weekend, twilight and nights as per business needs (compensated with flexi time).
WHO YOU ARE
- Bring a proven track record of working in a fast-paced and demanding hospital or industrial Lab setting, with the ability to deliver results within short cycles.
- Lab team supervisory experience is also a MUST.
- Current knowledge of ICH-GCP standards.
- Bachelor's Degree in one of the Life Sciences.
AND/OR
- Experience working in GCP, cGMP and/or GLP environments
A big PLUS: Six Sigma Green Belt
ON A NORMAL DAY, YOU WILL
Learn. And grow. No two days will be the same because you will be exposed to a wide variety of Therapeutic Indications and study types (single and multiple ascending dose, first-in-human, food effect, drug to drug interactions, radiolabelled human AME, etc.)
The core of your work will be supporting International Phase 1 clinical trials being conducted in the clinic. All our teams in Drapers Yard live to answer one question: is the drug safe? Under this framework, you will:
- Provide leadership, training, coaching and mentoring to a team which may consist of Lab Technicians, Admin roles and Sample Coordinators so they deliver quality data on time, in strict accordance with relevant protocols, SOPs, and in compliance with ICH/GCP
- Play an active role in the development and implementation of Quality systems within the Lab. In particular, you will support your team to conduct these Lab specific core processes to the highest possible quality: blood, urine and fecal samples and process and dispatch of lab´s safety samples
- Support your Team members through the Planning of Study set up (from protocol review and software set up, to the creation of essential documents such as lab manuals or forms, and all labelling and sample tube preparation)
- Build an impactful team: interview & hire new team members and nurture talent with full cycle performance management (managing KPIs, weekly 1:1s, performance discussions, development and career progression, discipline conversations when needed).
- Lead by example and actively support the culture and values of the Fortrea Clinical Research Unit at Drapers Yard.
- Craft new training plans, design training materials and delivery. Ensure that all team member training files are up to date and complete in accordance with SOPs and ICH/GCP
- Lab safety oversight and compliance. Ensure that a safe working environment is maintained in the Lab, and that safe working practices are employed.
- Full oversight of on-site client audits
- Drive continuous improvement and best practices throughout the lab, identifying opportunities for process optimization and efficiency gains.
WHERE FROM HERE?
With our expansion plans our expectation is that you have the opportunity to f oversee not only a bigger team, but also a more varied team, expanding from Lab-only to other functions within clinical operations.
THERE IS ONE THING THAT ONLY FORTREA CAN OFFER
You will work with the clinical trial participants next door Under the same roof, we have: the clinic, a state-of-the-art processing laboratory and cutting-edge cGMP pharmacy and a state-of-the-art Lab. Supporting these functions we also have all elements of the full clinical Pharmacology Service including Data Management, Medical and Scientific, regulatory affairs, statistics and biometrics, all of which provides you with a hands on opportunity to develop your career within Fortrea.
You will witness firsthand the dosing and safety research as they are being conducted in real time. When the drug you worked with gets approved, you know you´ll touch many patient´s lives around the world.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inc
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