Company Overview

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,300 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.

Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

The Role

Due to our continued growth and success a great opportunity has arisen for a CMC Coordinator to join our Manufacturing team based in Reading.

You will be responsible for co-ordinating and implementing all documentation activities required for pharmaceutical development, CMC, clinical trial manufacturing, GMP/GCP handover and IMP labels.

Other main tasks and responsibilities include:

• To act at all times in compliance with Good Manufacturing Practice (GMP) and report any issues.
• Regular communication with Manufacturing, Development, Technical Operations, Quality and Project Management teams to ensure batch manufacturing records, IMP labels, raw materials and consumables, equipment, study-specific documentation, and training packs are in place prior to CMC and clinical trial manufactures.
• Responsible and accountable to ensure study paperwork is in place in good time for manufacture
• Lead at CTM Readiness meetings and attend key study-specific meetings
• Bridge the knowledge gap and transfer of information between Development and Production teams.
• Author documents where required (BMRs, work instructions, cleaning documents, SOPs etc).
• Train the manufacturing team in study-specific batch manufacturing record use and completion.
• Communicate the progress of development and clinical trial manufacturing projects effectively to Manufacturing management, QA and Project Management teams as required, to allow realistic goals to be set and to allow clients to receive timely information on project achievements or issues arriving.
• Review of pre and post executed BMRs and BPRs
• QE and RCA investigator
• Identify and lead continuous improvement activities
• Act as deputy for Production Study Manager with regards to all colour team project deliverables.

The Candidate

• Ideally have a degree in a Science subject.
• Significant clinical trial manufacturing experience or CMC Development experience
• Excellent interpersonal and communication skills
• Excellent organisational, problem solving and follow up skills
• Ability to perform multiple tasks and prioritise effectively
• Excellent attention to detail

Applicants must have the right to work in the UK upon being offered employment.

Company benefits

In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.

Our Commitment to Diversity & Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion.

We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.

As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.

If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at Quotient.