Production Study Manager

Job Title:Production Study Manager
Location UK ~ Reading
Type: Full Time, Permanent

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 Production Study Manager to join our Manufacturing team based in Reading.

You will have accountability to ensure that product and process development, and manufacturing activities for investigational Medicinal Products are delivered on time and to the required quality and regulatory standards.

Other main tasks and responsibilities include:

  • Responsible and accountable for project delivery post-CMC batch manufacture, specifically the OTIF and RFT cGMP manufacture of IMPs
  • Oversight for all production study activities including ensuring documentation is ready on time, supplies are on site and schedules are deliverable
  • Ensuring completion of CTMs to deadlines ensuring sufficient resources, equipment and materials are in place to ensure OTIF delivery
  • Provision of effective and efficient technical support in the scientific aspects of clinical trial manufacturing
  • Communicate progress of clinical manufacturing projects effectively to clients and Quotient Sciences staff as required, to allow realistic goals to be set & to allow clients to receive timely information on project achievements or issues arriving.
  • To be knowledgeable of, and to follow, the current relevant production guidance, rules and regulations detailed in the, Guidance for Pharmaceutical Manufacturers and Distributors (2007), the Clinical Trials’ Directive, the GMP Directive and the associated UK implementing statutory instruments for these Directives, when concerned with the for the receipt, storage, security, supply, labelling, reconciliation and manufacture of investigational medicinal products.
  • Review of pre and post executed BMRs and BPRs
  • QE and RCA investigator
  • Line management responsibility for a Manufacturing team
  • Deliver continuous improvement activities

The Candidate

  • Ideally have a degree in a Science subject.
  • Significant clinical trial manufacturing experience or CMC Development experience
  • Line management 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.