This is a Permanent, Full Time vacancy that will close in {x} days at {xx:xx} BST.
The Vacancy
The purpose of this role is to support the activities of the Cell and Gene Therapy Catapult’s GMP Quality Control Laboratories and associated infrastructure. Reporting to the Head of Quality Control, this role will help ensure that the Manufacturing Centre meets the standards and expectations of its key stakeholders; regulatory authorities; and potential collaborators.
Key Accountabilities:
QC Laboratory Support – e.g. Environmental monitoring, raw material inspections/testing, in-process, final product and sterility testing:
Support the tactical execution of laboratory analysis and result reporting to assure the QC service provision associated with viable environmental monitoring, starting material, raw material, excipient, in-process and final product sample testing is maintained in line with the requirements of each collaborator.
As required work with QC personnel, QA, suppliers and service providers to assist in the development and maintenance of GMP compliant QC Laboratory services.
Undertake non-guaranteed overtime as per the Company policy in response to an operational need.
QC Sample Management & LIMS Management:
Support the Sample Management function to ensure the QC group provides a timely, effective and efficient service for the collection (from manufacturing modules and other classified areas), transportation, storage and lifecycle management of collaborator and CTG derived microbiology and environmental monitoring samples requiring testing.
Support collaborator raw material sampling activity and ensure it is undertaken to GMP and in accordance with collaborator requirements.
Microbiology:
Conduct environmental monitoring of the allocated area as per scheduling.
Undertake the Microbiological analysis according to specifications and methods.
Report the progress of daily activities to the Senior Technician/QC Specialist
Support microbiological Out of Specification investigations.
Regulatory Compliance:
Support to ensure the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standards.
Support to ensure all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately and with the appropriate degree of periodicity).
Support to ensure the CGT team and associated service providers complete all documentation and records accurately, contemporaneously and to a consistent GMP standard.
Support to ensure the traceability of all reagents, materials, equipment, standards etc. is maintained for all GMP sampling and testing activity.
Participate in Out of Trend, Out of Specification and Deviation management events associated with QC activity and assist in the reporting and management of such events to an appropriate and compliant conclusion.
Experience:
Experience working in microbiology or in an aseptic (bio)pharmaceutical manufacturing environment operating according to GMP.
Experience of looking critically at own and others work practices and procedures and identifying and implementing any needed improvements.
Knowledge / Skills / Competencies:
Highly motivated, pragmatic and practical to support the mission of the Cell and Gene Therapy Catapult to assist in the acceleration of the development of a commercial cell based therapy industry in the UK.
Project ownership and pride in its delivery.
Having a passion for delivering excellent customer service.
Flexibility towards work assignments and new learning.
Ability to manage multiple and varied tasks and prioritise workload with attention to detail.
Comfortable operating autonomously once goals and objectives are set.
Excellent interpersonal, written and verbal communication skills.
Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives.
Having current and up to date professional knowledge, expertise and best practice.
Ability to quickly establish credibility and build rapport and trust.
A good team player, with strong organisational skills.
Desire to establish a high profile career within cell and gene sector and the personal drive to help push the sector to be a commercial success.
Ability to work well under pressure, to work independently and to be able to take the initiative when completing tasks.
Ambitious, collaborative, driven.
Comfortable operating autonomously once goals and objectives are set.
Accurate with strong attention to detail.
Ability to quickly establish credibility and build rapport and trust.
Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives and to respond to a wide range of customer and management needs.
A positive attitude towards learning, personal and professional development.
Keeps up to date with professional knowledge, expertise and best practice.
Willingness to travel.
Education / Qualifications
Bachelor’s degree in Microbiology, Biotechnology, Molecular Biology, or related discipline.
The Company
The Cell and Gene Therapy Catapult was established as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation.
With more than 350 employees focusing on cell and gene therapy technologies, it works with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. It offers leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. Its aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies.
You Have already applied for this vacancy, please go to your account to see your progress.
Privacy Policy
Catapult Cell and Gene Therapy NEWPrivacy Statement
The following explains how we Catapult Cell and Gene Therapy NEW (Controllers) intend to use the information you provide in your application, along with your rights, our reasons for requesting it and who will have access to it.
As defined by the General Data Protection Regulation (GDPR) Catapult Cell and Gene Therapy is the Data Controller and ultimately responsible for ensuring the data you provide is kept secure, processed correctly and that you understand your legal rights in relation to the data you provide.
The recruitment software we use via this website is supplied by IRIS Software Group Limited and they are defined as a Data Processor under the GDPR. They will only process your data in accordance with our instructions.
IRIS can be contacted at: 4th Floor Heathrow Approach, 470 London Road, Slough, England, SL3 8QY
For Data Protection enquiries, please contact the Help Desk at support@networxrecruitment.com
What information do we collect from you?
We collect information that is specifically provided by you as part of an application process. We will collect the following (but not limited to):
Name, address, email, telephone number
CV (if applicable)
Equal opportunities monitoring information (defined as special categories data) - this information is purely for statistical analysis and monitoring purposes
Answers to application questions
Any other information you wish to provide in support of your application
We are using Contract as our legal basis for processing, which means we can use your details and information so that we may assess your suitability for employment with us, as well as carry out our statistical analysis of recruitment.
Why do we collect this information and who do we share it with?
Details you provide in this application:
Will be held on our computer systems and may be downloaded by us
Will be used to deal with your application
Will be made available to us and our processors
Will be used for communication with you regarding the vacancy
Will be used to satisfy legal requirements
Will be used for statistical analysis
Will be held and may be used to contact you about other vacancies
We will store your application data for 13 months after the vacancy has closed. After this period, it will be fully anonymised.
Only if you are successfully recruited, we will upload your details to our HR system, Cascade. As a member of staff you will sign a contract of employment and agree to additional terms on how your data is handled and stored.
We use DocuSign for digitally signed documents. You may be required to sign a contract, offer and/or other documents if you are successful. You will not have to create an account with them and we only pass on the minimum amount of data required to allow them to carry out their operations.
Please click the link below to view their privacy policy https://www.docusign.co.uk/company/privacy-policy
How can I access the information you hold about me? Your rights
We are dedicated to providing reasonable access to visitors who wish to review the personal information retained when they apply via our website site and correct any inaccuracies it may contain. If you choose to register, you may access your profile, correct and update your details, or withdraw your details at any time. To do this, you can access your personal profile by using the secure login. In all cases we will treat requests to access information or change information in accordance with applicable legal requirements.
You have the following rights in relation to the way in which we deal with your personal data:
the right of erasure or to be forgotten
the right to rectification if information is inaccurate or out of date
the right of data portability (to obtain and reuse your personal data)
the right to object to networx and the controller and processors handling of your personal data
the right to withdraw your consent with regards to the handling of your personal data
you have the right to ask for a copy of the information we hold about you (Subject Access Request - S.A.R)
You have the right to lodge a complaint with a supervisory authority - the ICO
Within your candidate account, you can also use the Download Data feature to generate an XML file of the current data we hold on you that you have provided and/or have access to within the account.
Where you exercise your right to object or withdraw your consent we may process your personal data without your knowledge or consent where we are permitted or required by law or regulatory requirements to do so. In such a case, we will not process more personal data than is required under the circumstances.
If you are not satisfied by our actions, you can seek recourse through our internal complaints procedure. If you remain dissatisfied, you have the right to refer the matter to the Information Commissioner (www.ico.org.uk) or seek recourse through the courts.
Catapult Cell and Gene Therapy NEW can exercise the right to update this policy as and when required.
Social Login
To continue creating your account, please read the privacy policy and tick the box below
To complete creating your profile with , please read and agree with the privacy policy.
The email used for your profile is not a valid company domain name. In order to
continue to create your profile with you will need to select a profile which uses a company authorised email address.
Cookie Preference Centre
Learn more about what each cookie category does and choose your settings
Cookie policy
Strictly Necessary
Name
__RequestVerificationToken
Duration
Session
Description
Anti-forgery Token
Name
ASP.NET_SessionId
Duration
Session
Description
General purpose platform session cookie, used by sites written with Miscrosoft .NET based technologies. Usually used to maintain an anonymised user session by the server.
Name
NTX_Cookie_Preferences_Live
Duration
6 Months
Description
Your cookie preferences
Performance / Analytics
Name
_ga
Duration
2 Years
Description
This cookie name is associated with Google Universal Analytics - which is a significant update to Google's more commonly used analytics service. This cookie is used to distinguish unique users by assigning a randomly generated number as a client identifier. It is included in each page request in a site and used to calculate visitor, session and campaign data for the sites analytics reports. By default it is set to expire after 2 years, although this is customisable by website owners.
Name
_gat
Duration
A few seconds
Description
This is a pattern type cookie set by Google Analytics, where the pattern element on the name contains the unique identity number of the account or website it relates to. It appears to be a variation of the _gat cookie which is used to limit the amount of data recorded by Google on high traffic volume websites.
Name
_gid
Duration
1 Day
Description
This cookie name is asssociated with Google Universal Analytics. This appears to be a new cookie and as of Spring 2017 no information is available from Google. It appears to store and update a unique value for each page visited.
Name
NetworxTracking_AdvertClick
Duration
90 Days
Description
Used for tracking if the candidate has already clicked the advert - used for analytics
Name
NetworxTracking_AdvertLoad
Duration
90 Days
Description
Used for tracking if the candidate has already loaded the advert - used for analytics
Functional Cookies
Name
ApplicationIntroductionID
Duration
90 Days
Description
Check to see if the candidate has already read the introduction for the Application
Name
FavouriteVacancies
Duration
30 Days
Description
Store any jobs the candidate has flagged as a favourite