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Director of Environmental Health & Safety - CARDIFF BASED
With the acquisition of Amersham Radiolabelling Services from GE Healthcare, Quotient Bioresearch has significantly expanded its capabilities and now operates from 2 sites in the UK – Northamptonshire and Cardiff.
As part of the transition of the Amersham business, Quotient is constructing a world class radiosynthesis facility in Cardiff which is due to open in early 2010.
The group offers a custom synthesis service to clients in the pharmaceutical, agrochemical and industrial sectors and over the years has acquired great experience in the development of synthetic routes, the isolation and analysis of chiral compounds and the preparation of radiolabelled macromolecules and peptides/proteins.
We are actively recruiting for a Director of Environmental Health and Safety. Principally based in Cardiff although with a corporate compliance responsibility this role would be expected to spend ~30% of time at other sites.
Principal Responsibilities:
To work with RPAs (internal and external) to ensure that appropriate Environmental compliance is being maintained in Cardiff and Rushden.
To work with Chair of EHS committee in Cardiff to strengthen and develop the EHS procedures and culture within the Cardiff site.
To develop a Chemistry & Metabolism monthly reporting tool for EHS compliance across the SBU with key metrics identified and reported.
To bring EHS compliance on the Rushden site under a framework that
To develop a program for building a corporate EHS compliance system for presentation to and agreement by the QBR executive board possibly through MD.
To monitor publications and attend appropriate meetings to advise Quotient on likely future EHS compliance issues and to work with business areas to develop effective strategies to embrace changes in a efficient way across the group.
To manage the environmental leader and the EHS team to help monitor contamination of laboratories and staff in Cardiff. This requires active and positive interaction with production, RPAs and RPSs. Play a key role in working with RPAs and EHS committees to efficiently collect, communicate and learn from data collected with the objective of identifying suitable corrective actions.
Other responsibilities:
To play an appropriate senior management role at the Cardiff site given the seniority of the position.
To be a strong team member with a recognition that solutions have to be found that meet business needs.
Facilities Engineer - CARDIFF BASED
With the acquisition of Amersham Radiolabelling Services from GE Healthcare, Quotient Bioresearch has significantly expanded its capabilities and now operates from 2 sites in the UK – Northamptonshire and Cardiff.
As part of the transition of the Amersham business, Quotient is constructing a world class radiosynthesis facility in Cardiff which is due to open in early 2010.
The group offers a custom synthesis service to clients in the pharmaceutical, agrochemical and industrial sectors and over the years has acquired great experience in the development of synthetic routes, the isolation and analysis of chiral compounds and the preparation of radiolabelled macromolecules and peptides/proteins.
We are actively recruiting for a Facilties Engineer:
Essential Qualifications and Experience
• Appropriate qualification in Mechanical & Electrical Installation/Maintenance such as HNC, City & Guilds
• Computer Literate in Word, Excel & Project
• Experience of providing engineering support to all aspects of the building services installation including Heating, Air-conditioning,
Medical Gases, building fabric and Mechanical & electrical services
• Experience of managing a Capital Works programme, driving the process from the design stage to completion.
Desirable Qualifications and Experience
• Experience and appropriate qualification in Waste Management
Executive Secretary - CARDIFF BASED
With the acquisition of Amersham Radiolabelling Services from GE Healthcare, Quotient Bioresearch has significantly expanded its capabilities and now operates from 2 sites in the UK – Northamptonshire and Cardiff.
As part of the transition of the Amersham business, Quotient is constructing a world class radiosynthesis facility in Cardiff which is due to open in early 2010.
The group offers a custom synthesis service to clients in the pharmaceutical, agrochemical and industrial sectors and over the years has acquired great experience in the development of synthetic routes, the isolation and analysis of chiral compounds and the preparation of radiolabelled macromolecules and peptides/proteins.
We are actively recruiting for an Executive Secretary reporting to Managing Director.
Location: Based in Cardiff at Regus Bay and then Trident Park
Reporting: Managing Director of Chemistry and Metabolism
Principal Responsibilities:
1. To coordinate collection of actions from the Trident Park project teams and update the database accordingly.
2. To circulate tasks report to the project overview committee and to provide other feedback reports to Trident Park project teams.
3. To arrange and take minutes from the project overview committee meetings. These should be scheduled every other week from
ASAP until end June 2010.
4. To provide administrative support to the Trident Bay group, Senior Management group in Cardiff and the Managing Director
Chemistry & Metabolism
5. To coordinate administrative tasks linked to the move, where actioned by the project teams.
This role is provisionally on for a 1 year fixed term contract although there is a strong possibility of this role becoming permanent.
ICT Support Administrator - CARDIFF BASED
With the acquisition of Amersham Radiolabelling Services from GE Healthcare, Quotient Bioresearch has significantly expanded its capabilities and now operates from 2 sites in the UK – Northamptonshire and Cardiff.
As part of the transition of the Amersham business, Quotient is constructing a world class radiosynthesis facility in Cardiff which is due to open in early 2010.
The group offers a custom synthesis service to clients in the pharmaceutical, agrochemical and industrial sectors and over the years has acquired great experience in the development of synthetic routes, the isolation and analysis of chiral compounds and the preparation of radiolabelled macromolecules and peptides/proteins.
We are actively recruiting for an ICT Support Administrator.
The ICT Support Administrator is primarily responsible for providing a range of services to the Quotient Cardiff site and supporting all desktop applications & hardware, network infrastructure, PBX systems and Windows Servers. The role includes the following accountabilities:
• Resolution of routine desktop support calls in a timely effective fashion
• Establish and maintain support call logs, ensure quality procedures are adhered to and maintain Local ICT Documentation systems
• Work on a variety projects as directed by the ICT Manager and local management teams
• Actively contribute to the continuous improvement of QBR processes (within and outside the ICT Department)
• Day to day administration and maintenance of the company’s network and Servers.
• Install and configure new systems
• Work as part of a multi-site team supporting over 150 users
• Be aware of external ICT developments and trends that may impact or benefit QBR
Essential Criteria
The successful candidate will be expected to show initiative, have excellent inter personal skills, be well organised and able to work both on their own and as an effective member of the team. Demonstrable experience with Windows Server 2000/2003/2008, Vista, XP, 2000 and NT4 operating systems, Active Directory, Exchange, TCP/IP and Office Applications is essential. An appropriate MCSA/MCITP qualification is essential, and training will be provided to keep skills current. A full clean UK driving license will be required to support the two Edinburgh sites.
Desirable Criteria
Experience with the following technologies is desirable:
• Administration of Oracle and/or MSSQL Databases
• Experience with backup software technologies
• Intranet technologies such as Windows Sharepoint Services 3.0
Project Management Associate - EDINBURGH BASED
Job Title: Project Management Associate
Reporting to: Director, Project Management
Summary of job purpose
To support project management in the completion of allocated projects to the agreed standards of quality, to agreed timelines and within cost budget.
Qualifications & experience required for competent performance
• Minimum Degree qualification or equivalent.
• Some relevant work experience in a pharmaceutical company or CRO would be an advantage.
Main responsibilities
• Assist in protocol and subject information leaflet writing activities
• Preparation of treatment allocations
• Management of CRF generation and review
• Generation of study day paperwork as appropriate
• Assist with internal data generation such as adverse event summaries, as required for ongoing client reporting
• Host client monitoring visits, as requested by Project Managers
• Manage CRF sign off and shipment to time line
• Assist Project Managers with close down activities such as archiving
• Manage data query resolution within agreed time lines
• Action process improvement changes as delegated by the Director, Project Management
• General support to the Project Management group
Stores Person - CARDIFF BASED
With the acquisition of Amersham Radiolabelling Services from GE Healthcare, Quotient Bioresearch has significantly expanded its capabilities and now operates from 2 sites in the UK – Northamptonshire and Cardiff.
As part of the transition of the Amersham business, Quotient is constructing a world class radiosynthesis facility in Cardiff which is due to open in early 2010.
The group offers a custom synthesis service to clients in the pharmaceutical, agrochemical and industrial sectors and over the years has acquired great experience in the development of synthetic routes, the isolation and analysis of chiral compounds and the preparation of radiolabelled macromolecules and peptides/proteins.
We are actively recruiting for a Stores Person.
Duties
Maintain stores in an organised manner. Ensuring stores area is clean.
Environmental conditions are monitored to ensure correct conditions are maintained in relation to stock being stored. Adherence to COSHH requiriments
Receipt and booking of incoming goods, checking physical condition of the delivery, cross checking against the purchase order, locating goods in the appropriate stores area or passing onto personnel.
Pick stock according to BOM instructions and updating stock records
Receipt and booking of completed works orders, locating goods in the appropriate stores area
Timely delivery of Stores and non-radioactive waste Services.
To monitor and maintain non radioactive waste disposal procedures in a cost effective and practical manner. Along with being aware of the importance of environmental matters and ensuring waste is recycled where possible
Carry out stock checks as required, review stock levels and identify changes in demand. Maintain minimum stock levels of laboratory consumables
To promote and maintain good communications with internal customers.
Essential Criteria
Show initiative – self-starter
Be well organised
Able to work on own and as part of a small team
Computer literacy
Good communication skills
Good record keeping
Physically fit.
Previous experience of working in a store/manufacturing environment.
Familiarity with COSHH
Experience with Environmental issues.(Courses attended)
Forklift licence
Logistics Manager - CARDIFF BASED
With the acquisition of Amersham Radiolabelling Services from GE Healthcare, Quotient Bioresearch has significantly expanded its capabilities and now operates from 2 sites in the UK – Northamptonshire and Cardiff.
As part of the transition of the Amersham business, Quotient is constructing a world class radiosynthesis facility in Cardiff which is due to open in early 2010.
The group offers a custom synthesis service to clients in the pharmaceutical, agrochemical and industrial sectors and over the years has acquired great experience in the development of synthetic routes, the isolation and analysis of chiral compounds and the preparation of radiolabelled macromolecules and peptides/proteins.
We are actively recruiting for a Logistics Manager:
Duties
Develop and operate system to ensure the safe, cost effective and compliant delivery of radioactive products manufactured at Trident Park to Client’s facilities, including the management of sub-contracted storage and shipment of products
Develop and maintain procedural documentation systems that meet internal and external regulatory requirements
To work with Business Development and Regional Sales Specialists to obtain the information required for delivery and shipment including the development and operation of databases to hold information on Client’s delivery addresses, licenses, consignee name etc.
To work with Manufacturing to ensure shipments are efficiently co-ordinated with the completion of synthesise or supply from stock. Arranging re-stocking as required
To work with Purchasing & Stores to Manage, co-ordinate and control the levels of packaging materials held in stock, to ensure material availability and maintain cost effective stocking levels
To work with Stores in the organisation of works orders and associated documentation to allow timely manufacture of products. Updating of works orders and stock movements
Analysing data to monitor performance and plan improvements
To work with Purchasing on the tendering and management of couriers and other shipping issues to ensure services are cost effective whilst meeting client needs
To confirm with Clients and/or Business Development that packages have been delivered and accepted.
Essential Criteria
Previous experience of working in a supply chain or logistics role.
Experience in International shipment of specialist packages
Qualified as a Dangerous Goods Safety Advisor (DGSA)
Experience in shipping radioactive materials
Experience in working with Clients in a service environment
Key Skills
A practical, logical and systematic approach with good project management skills
Close attention to detail and the ability to sort and sift facts, noting and responding to inconsistencies
Possess strong analytical troubleshooting and problem resolution skills and the ability to prioritise projects and process multiple tasks as required.
Team player
Excellent IT skills
Ability to communicate with others in an effective and concise manner
Manufacturing Scientist - NOTTINGHAM BASED - TEMP & PERM VACANCIES
Summary of job purpose
Responsible for the manufacture of Investigational Medicinal Products for all types of clinical studies performed at Quotient Clinical. To develop and validate production methods (including radiolabelling) for all types of clinical study performed at Quotient Clinical and at all times being vigilant in both radiation and chemical safety measures to reduce the exposure of themselves and others to radiation or hazardous materials. To transfer these methods successfully into GMP clinical manufacturing, with input on manufacturing protocols, validation criteria and other key parameters.
Qualifications & experience required for competent performance
• Degree level qualification in a science subject and
• Some relevant work experience
Or
• Substantial work experience (GMP/GLP) in similar type of work
Main tasks and responsibilities
• Manufacture of pharmaceuticals to cGMP standards (In-vivo) and internal SOP standards (In-vitro) and associated laboratory activities.
• Provision of effective and efficient technical support in the scientific aspects of clinical studies (including: radiolabelling method development, validation and transfer to GMP/ in-vivo manufacturing).
• Direct involvement in tasks associated with the running and maintenance of the GMP cleanroom.
• Plan and complete weekly workloads based on the schedule of in-vivo and in-vitro activities provided by the D,CTM or nominated deputy.
• Ensuring that repetitive laboratory procedures are carried out in a reproducible manner with the minimum number of avoidable errors.
• Keeping detailed and accurate records of all work undertaken, ensuring that all records are clear, concise and legible at all times to enable for full repetition and traceability.
• Interpretation and communication of results as specified by the D,CTM or nominated deputy in accordance with SOPs of the Company.
• Performing day to day activities so as to ensure the smooth running of the Manufacturing Operations group, within the Pharmaceutical Sciences Department of the Company, in line with written Protocol and /or Standard Operating Procedures of the company.
• Storage, use and disposal of Radioactive Isotopes in line with regulatory requirements and internal SOPs, to include liaising with Radiation Protection Supervisor (RPS) or nominated Deputy on any radiation protection issues that may arise.
• Working in a safe responsible manner at all times.
• To communicate progress of in vitro and in vivo projects effectively to the D,CTM, Vice President (VP), Pharmaceutical Sciences or other Quotient Clinical staff as required, to allow realistic goals to be set & to allow clients to receive timely information on project achievements or issues arriving.
• As part of the Pharmaceutical Sciences Department, undertaking procurement, booking in, sampling, reconciliation and controlled disposal of In-vitro and clinical (In-vivo) supplies as applicable.
• Performing other duties as reasonably required.
Clinical QA Associate - NOTTINGHAM BASED
Summary of job purpose
Ensuring operations are compliant with internal procedures and regulatory requirements
Supporting the provision and development of efficient and effective Quality Assurance (QA) systems for clinical and scientific research studies
Qualifications & experience required for competent performance
• At least 2 years experience and knowledge of auditing (to either GCP, GMP, GLP or vGCP standards) or clinical research operations (e.g. as CRA, monitor, project management, etc)
• Knowledge and understanding of Clinical Trials and the regulations governing Clinical Trials in the UK
• Experience of discussing quality/compliance issues with senior managers and ensuring satisfactory resolution
• Experience of writing SOPs (or similar written procedures)
• Experience of developing training methods and carrying out training for staff at all levels desirable
• Experience of using QA software packages (e.g. QAAD, Trackwise, etc) desirable
• Willingness to travel (mainly in UK, but with possibility of occasional travel abroad) – estimated to be no more than 10% of working days per year
• Science-based degree preferred (e.g. biology, chemistry, statistics, engineering), but willing to consider other equivalent training or vocational experience
• Keen eye for detail and logical approach to performing tasks
Main tasks and responsibilities
• Monitoring compliance of PP operations with internal procedures and regulatory requirements
o Internal audits performed in either clinical, laboratory or manufacturing areas
Documentation audits, process audits, facility audits
o Vendor audits cover a wide range of suppliers and subcontractors used by PP, such as IT suppliers, clinical laboratories, raw material manufacturers, etc
• Communication of quality/compliance issues to departmental and senior managers by means of written reports, presentations and discussions
• Involvement in sponsor audits as required
• Involvement in regulatory inspections as required
• Conducting competency-based and GCP/GMP training as required to staff
• Involvement in development and implementation of the Company quality system as required.
• Review of relevant documentation; including SOPs, clinical protocols and research reports
• Involvement in quality issue investigations (e.g. process deviations, GXP incidents) and corrective action follow up
• Planning, conduct, reporting and following up of internal & external audits
• Interpretation and communication of information (e.g. regulatory requirements) and provision of advice on quality issues to members of staff and clients as required.
• Use of QA electronic activity management system, with possibility of role of system administrator
• Performance of other duties as reasonably required.
To apply for this role please send your CV & covering letter to careers@quotientbioresearch.com.
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