Production Manager – Cell Therapy Products
Scottish National Blood Transfusion Service
Permanent
Research, Development and Innovation, Scottish Centre for Regenerative Medicine,
Edinburgh
Band 8A – Salary Scale: £39,632-£47,559
As a vital part of NHS Scotland, NHS National Services Scotland’s purpose is to support Scotland’s Health. We do
this by providing a range of specialised support services that enable NHS Boards to focus their efforts on health
improvement and delivering world class patient care.
The core purpose of the Scottish National Blood Transfusion Service is to meet the transfusion needs of patients in
Scotland. In support of this, the SNBTS Research, Development and Innovation (RDI) Directorate is committed to
a programme that will enhance the service provided to NHSScotland in both clinical and operational areas. SNBTS
undertakes research and development which is designed to support the strategic and operational priorities of the
organisation, achieve high quality and impact and add value to broader NHS and Governmental objectives.
Research at SNBTS RDI is divided into 3 theme groups – Microbiology and Components, Clinical Transfusion, and
Tissue & Cellular Therapies.
This is an exciting opportunity to join the SNBTS RDI Directorate as a Production Manager, Cell Therapy Projects.
The successful candidate for this new post will be integral to the efficient running of the Cellular Therapy
Development Centre with specific responsibility for all GMP-related activities pertaining to products, samples and
controlled environments. The post holder will have a variety of responsibilities including budgetary management,
delivering internal and external projects to strict timelines, and management of production and QC staff.
The successful candidate must be educated to degree level with a relevant postgraduate qualification or equivalent
competence. In addition, the post holder must have demonstrable experience resulting in specialist knowledge of a
range of procedures and processes in the GMP manufacture of tissue and/or cellular therapy products. Experience
in supervision/management and the ability to motivate an interdisciplinary manufacturing team in order to deliver a
complex clinical service is also essential.
Our benefits package includes final salary pension scheme, comprehensive range of work life balance policies,
occupational health services, learning resource centres and discounted leisure, financial and shopping benefits.
Interested applicants are encouraged to contact the Dr Neil McGowan, Cell Therapy Product Manager for an
informal discussion about the role. neil.mcgowan@nhs.net, tel. 0131 651 9572
For an application pack please complete the online application form on the SHOW website www.jobs.scot.nhs.uk.
Ref G26222. Please note that CVs will not be accepted.
Closing date for completed applications is 12 noon on 4th November 2014.
Please note that only those applicants called for an interview will be contacted. If you have not received a
response within 4 weeks of the closing date, please assume that you have been unsuccessful on this
occasion.
Further information on NSS is available from: www.nhsnss.org.
NHS National Services Scotland is the common name of the Common Services Agency for the Scottish Health
Service.
NHS National Services Scotland is an equal opportunities employer.
Candidates with disabilities who meet the minimum selection criteria will be guaranteed an interview
NHS NATIONAL SERVICES SCOTLAND
JOB DESCRIPTION
1.
JOB DETAILS
CAJE Ref. No: NPBTCS032
Job Holder
Job Title
Cellular Therapy Production Manager (AFC band 8a)
Immediate Senior Officer
Cellular Therapy Project Manager
Division
Research, Development & Innovation
Location
Scottish Centre for Regenerative Medicine
2.
JOB PURPOSE
To manage the Scottish Centre for Regenerative Medicine (SCRM) GMP Cellular Therapy Facility (GMP
CTF) to allow the safe provision of efficacious cell therapy products for clinical trials on a timely basis,
meeting all appropriate quality and regulatory standards. To manage the development of the SCRM GMP
manufacturing service in line with future clinical trials.
3.
DIMENSIONS
This post will be based at the Cellular Therapy Development Centre within the SCRM.
This post is integral to the efficient running of the Cellular Therapy Development Centre with specific
responsibility for all GMP-related activities pertaining to products, samples and controlled environments.
The Cellular Therapy Development Centre is composed of Cellular Therapy Project Manager, Cellular
Therapy Production Manager, Cellular Therapy Scientists, QC Analyst and MLA in addition to senior RDI
staff.
This post will have budget responsibilities for the SCRM GMP CTF, with line management responsibility for
the QC Analyst, MLA and other grant-funded Cell Therapy Manufacturing Scientists.
4.
ORGANISATION CHART
RDI Associate Director
Cellular Therapy Project Manager
Cellular Therapy Production Manager
QC Analyst
Analyst
MLA
Grant-funded CT
Man. Scientists
5.
ROLE OF THE DEPARTMENT
The core purpose of the Scottish National Blood Transfusion Service is to meet the transfusion needs of
patients in Scotland. In support of this, the SNBTS RDI Directorate is committed to a programme that will
enhance the service provided to NHS Scotland in both clinical and operational areas. SNBTS undertakes
research and development which is designed to support the strategic and operational priorities of the
organisation, achieve high quality and impact and add value to broader NHS and Governmental objectives.
SNBTS research is organised into four research themed areas, aligned to one of the 3 SNBTS operational
directorates (Tissue and Cellular Therapies; Clinical Transfusion; Blood Donation, Processing and
Testing). RDI also interfaces with both the main research intensive Scottish Universities in Edinburgh,
Glasgow, Aberdeen and Dundee and with partner organisations such as the National CJD Surveillance
Unit and Roslin Cells. SNBTS RDI also works in partnership with other research-active Divisions of NSS,
wider NHS Scotland and with other UK Blood Services in order to ensure clinical relevance and efficient
use of resources.
Cellular therapies are manufactured to GMP within the SCRM based at Little France, Edinburgh. This
state of the art cleanroom facility is shared with Roslin Cells Ltd. and licensed by both the MHRA and HTA
for the GMP translation of novel cellular therapies for use in first in man and/or Phase I/II clinical trials.
6.
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KEY RESULT AREAS
Responsible for the day to day management of the SCRM GMP CTF to ensure that procedures,
equipment and facilities are operated according to GMP.
Line management of key technical and manufacturing staff involved in the delivery of GMP cellular
therapies.
Manage the cleaning, environmental monitoring, equipment maintenance and housekeeping of the
cleanroom and associated laboratory areas to ensure that the SCRM GMP CTF remains GMP
compliant at all times.
Coordinate the production of a range of cellular therapy products and participate in aseptic cleanroom
procedures as required to provide safe and efficacious cell therapy products according to GMP to
meet the appropriate regulatory standards and the requirements of clinical trials.
Be responsible for the coordination of, through communication with source hospitals/testing
laboratories, the receipt and processing of tissues/cells, samples and documentation from donation
through to transplant, to ensure the maintenance of the product audit trail.
Interpret and evaluate QC results and assess product quality through the application of professional
and clinical knowledge. Apply outcome of this analysis to allow products to be cleared for clinical use.
Be responsible for the continual review of manufacturing procedures, including the maintenance and
review of standard operating procedures to incorporate new technology/standards to ensure continued
licensing by the MHRA and HTA.
Analysis & interpretation of SCRM GMP CTF environmental data to ensure compliance with relevant
standards.
Be responsible for ensuring the confidentiality and security of all data relating to donors and recipients
is maintained at all times by SCRM GMP CTF staff.
To be familiar with the aims, policies and future plans for the SNBTS Cellular Therapy Development
Centre.
Maintain a working knowledge of UK laws and regulations relating to the GMP manufacturing of
cellular therapy products and understand the requirements for these products and their clinical
importance.
Maintaining an awareness of appropriate scientific literature so that work is carried out according to
up-to-date knowledge and practice.
Manage implementation of policy and suggest changes to working practice as appropriate.
Be responsible for the implementation and validation of new products/procedures and/or service
developments.
Manage the preparation of controlled documentation for new procedures to enable developments to
be introduced in a suitably controlled manner.
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7.
Responsible for managing the SCRM GMP CTF budget in consultation with Cellular Therapy Project
Manager.
Responsible for sourcing, costing & purchase of physical assets.
Authorised signatory for payment of on-call / out of hours claims & expenses.
Safe use of complex laboratory equipment.
Coordinate the GMP training requirements of the department in accordance with national standards.
The presentation of data at local, national and international level.
Responsible for the compilation of management & activity statistics.
Participate in the on-call rota to cover equipment failure and out of hours processing/issue
requirements.
Contribute to R&D projects and/or GMP translational projects as required to ensure the smooth
transition of new projects into the facility.
Apply computer knowledge and keyboard skills to interface with the software controlling the receipt,
tracking and issue of patient medical, processing and product data, ensuring that associated files are
GMP compliant, kept orderly and up to date.
Participate in continual personal training and development as a member of a small team in a unique
area of health care, ensuring up-to-date knowledge and skills.
Input of clinical and laboratory data in both paper and electronic form ensuring accuracy and legibility
at all times.
Develop, maintain and use a wide range of laboratory documentation which includes writing, reviewing
and updating SOP’s and associated forms/worksheets, COSHH and risk assessments, incident &
OOS reports, change controls and validation protocols/reports to ensure a consistent and controlled
approach to laboratory activities and maintain GMP compliance.
Carry out all duties and responsibilities according to approved SNBTS policies and procedures which
are designed to comply with the EU guidelines on GMP (Eudralex Vol. IV).
Participate in internal audits and external regulatory authority inspections to ensure inspectors are
informed accurately of current practices and procedures.
ASSIGNMENT AND REVIEW OF WORK
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Monthly meetings with be held and objectives set in discussion with the Cellular Therapy Project
Manager.
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The post holder must be able to work independently and unsupervised, managing and prioritising their
own workload, whilst coordinating the needs of the department and allocating roles to staff
accordingly.
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The individual will be expected to supervise the work of others in accordance with current guidelines.
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Review: Cellular Therapy Project Manager will review success in key result areas.
assessment of performance will be reviewed annually as part of eKSF.
8.
Formal
COMMUNICATIONS AND WORKING RELATIONSHIPS
 Liaise with other SNBTS staff and senior Roslin Cells staff regarding the management of the SCRM
GMP CTF.
 The postholder will provide and receive complex and/or sensitive information. This information will be
in the form of oral, written, electronic or face-to-face and come from or be given to:
- Other colleagues in SNBTS i.e. RDI Associate Director, Cell Therapy Project Manager, QC
Laboratory Controller, Quality Manager, senior scientific staff, BMS’s, Clinical Scientists, QC
analysts, MLAs etc.
- Internal and external medical, nursing and scientific staff to advise end-users on quantity / quality &
effective use of cell therapy products and to arrange their timely delivery. Modify manufacturing
schedule in order to accommodate the fluctuating requirements of clinicians pertinent to patient
need.
- External customers and regulatory authorities regarding test results, products, reagents, equipment
etc.
9.
MOST CHALLENGING PART OF THE JOB
Coordinating complex and laborious manufacturing procedures in the SCRM GMP CTF to ensure safety
and efficacy of cellular therapy products and processing environments, while balancing all of the competing
priorities of the team and multiple projects.
Although the ultimate objectives of research projects are defined at the start, the steps towards achieving
these may not be obvious, even to an individual experienced in the field. This requires an ability to think
creatively and develop innovative and possibly unconventional approaches to solving specific problems as
well as a degree of self-confidence and effective communication with both peers and managers.
Working to tight deadlines and budgets is also an important challenge. Therefore it is important that the
individual can work to defined targets.
10.
SYSTEMS
Experimental data is processed and analysed using statistical packages supplied on the software provided
on the PC workstations and on software purchased for specific applications. The post holder will be
expected to be proficient in the use of spreadsheets and databases for the storage, manipulation and
presentation of experimental data. Includes creation and maintenance of databases containing records of
transplants/infusions, stock records of chemicals; records of cells stored in liquid nitrogen. Will be
responsible for co-ordinating the receipt, storage and reporting of investigations on samples and products
for specialist investigation and analysis, including the appropriate storage and maintenance of records.
Specifically:
 As a delegated budget holder and line manager, will be trained to use the NSS Financial Information
System (PECOS) for the requisition and receipt of goods/services and HR programs respectively.
 The Microsoft Office suite is used extensively throughout the working day and competence in this,
especially Word and Excel is required.
 The Tissue TraceTM database system used for controlling blood sample donations and is used on a
weekly basis.
 QPulse is used for document control, incident reporting and asset management on a daily basis.
 TREND 963 and Pharmagraph systems are used on a daily basis as Building Management and
Environmental Management systems respectively.
11.
WORKING ENVIRONMENT AND EFFORT
Physical Effort
There is a frequent requirement for prolonged sitting in a restricted position:
 At microscopes observing cells in culture.
 Extended working within cleanroom environments at Microbiological Safety Cabinets maintaining
aseptic environment to ensure sterility of final product, with only eyes exposed to the external
environment.
 Physical skills include repetitive activities such as pipetting and dissection/processing of human
tissue/cells.
Mental Effort
 Frequent requirement for intense concentration within the work period. Post holder is involved in
making decisions relating to GMP manufacturing and subsequent release of products.
 There is need to respond to the unpredictable nature of a biological product and adapting to the many
changes in working practice in a rapidly developing speciality.
Emotional Effort
 Stress may be encountered when dealing with tight manufacturing deadlines. There may also be
confrontational issues when discrepant or erroneous results occur.
 Occasional exposure to distressing or emotional circumstances e.g. receiving information on patient
medical conditions, information pertaining to cadaveric tissue/cell donations.
12.
ENVIRONMENTAL / WORKING CONDITIONS & MACHINERY AND EQUIPMENT
 Frequent exposure to hazardous working conditions, including:
- Handling samples in cold environments such as -40C to -80C freezers
- Working with protective gloves handling frozen products and reagents.
- Working with dry ice and liquid nitrogen.
- Working for long periods under class A and B clean room conditions
 Frequent use of VDUs, microscopes and a variety of specialised laboratory equipment on a daily basis.
 Direct contact with untested blood samples and tissues.
 Processing and disposal of tissues/cells known to be positive for virology markers or microbiological
contaminants.
 Responding to call outs during the night and weekends to cover equipment failures.
 Exposure to a variety of hazards on a daily basis. These include chemicals (corrosive, poisons,
flammable, toxic and harmful) and gases (flammable, compressed, explosive and asphyxiating).
13.
QUALIFICATIONS AND/OR EXPERIENCE SPECIFIED FOR THE POST
 Required to hold an honours degree in an appropriate biological science with an extensive knowledge
base and experience gained from post graduate qualification or equivalent.
 Demonstrable experience resulting in specialist knowledge of a range of procedures and processes in
the GMP manufacture of tissue and/or cellular therapy products.
 Must undertake Continuous Professional Development to maintain knowledge relevant to the
requirements of GMP cellular therapy manufacturing.
 Experience in supervision/management and the ability to motivate the SCRM GMP CTF
manufacturing team to work efficiently and effectively in order to deliver a complex clinical service.
14.
JOB DESCRIPTION AGREEMENT
A separate job description will need to be signed off by each jobholder to whom the job description applies.
Job Holder’s Signature
Date
Head of Department
Signature
Title
Date
HR Department will check job description format and content and then send the job description to the AfC
Team
HR Representative’s Signature
Date Job Description Agreed:
PERSON SPECIFICATION
This form must accompany the Job Description to which it refers.
Job Title
Cellular Therapy Production Manager
Job Reference
G26222
AfC Band
8a
Requirement
QUALIFICATIONS
TRAINING
EXPERIENCE
Essential
Proven experience as a manager or
senior scientist working in an
academic or healthcare/clinical
laboratory.
Desirable
Experience of working within a GMP
regulated (HTA/MHRA) environment.
Qualified to honours degree level in
biological science or related subject.
Postgraduate qualification or
equivalent experience.
Good interpersonal skills,
communicating effectively.
Able to implement new and changing
technologies to the appropriate GMP
standards.
Must be computer literate.
Experience in the organisation and
scheduling of multiple projects
concurrently.
PERSONAL QUALITIES
Clear evidence of enthusiasm, selfmotivation and initiative.
Demonstrates a willingness to work
hard in a demanding environment.
GENERAL
Able to work independently without
direct supervision and manage a
team of GMP production scientists
and technical staff.
Able to be flexible with hours of work.
Experience in presenting work to
varied groups of colleagues and
collaborators
Keen on new challenges, highly
motivated with evidence of ambition
to work in healthcare science.
Summary of Key Terms and Conditions of Post
Division/Department:
Blood Tissues & Cells
Location:
Edinburgh
Job Title & AfC Pay Band:
Production Manager – Cell Therapy Products, Band 8a
Salary/Salary Scale:
£39,632 - £47,559 per annum
Conditions of Service:
Your terms and conditions of service are in accordance with the Agenda for Change
Terms and Conditions Handbook. Agenda for Change comprises a National pay system
and job evaluation scheme for the Health Service, a harmonised set of terms and
conditions of employment and a Knowledge and Skills Framework.
Hours of Duty:
The standard full-time hours for NHS staff are 37.5 hours, exclusive of meal breaks,
normally to be worked over 5 days per week. The hours of this post are 37.5.
Annual Leave:
The annual leave arrangements are:
o
o
o
27 days (202.5 hours) on commencement
29 days (217.5 hours) after 5 years’ service
33 days (247.5 hours) after 10 years’ service.
8 public and statutory holidays are also available within the leave year.
Superannuation:
All new entrants to NHS National Services Scotland who are
aged sixteen but under seventy five will be enrolled
automatically as a member of the NHS Superannuation
Scheme (Scotland). The pension scheme is provided by the
Scottish Public Pensions Agency. This scheme is a
Qualifying pension scheme, which means it meets or exceeds
The government’s new standards. All benefits including life
Insurance and family benefits are explained on the SPPA
Website www.sppa.gov.uk
For further information on
Membership benefits, contributions, or how to opt out of the
Scheme, please refer to the enclosed factsheet “Auto
Enrolment.
Medical Assessment:
Appointment to this post will be subject to satisfactory medical clearance. The successful
candidate will be required to complete a pre-employment health declaration form and,
where appropriate, undergo a health assessment by the Occupational Health Service.
Knowledge and Skills
Framework:
The NHS Knowledge and Skills Framework applies
to all jobs covered by Agenda for Change. Under the Knowledge and Skills Framework,
staff will have annual development reviews, which will result in the production of a
personal development plan.
There is equal access to training for all staff.
Equal Opportunities Policy:
NSS is an Equal Opportunities employer and the policy applies to all aspects of
employment.
Smoking Policy:
NSS operates a No Smoking Policy.
Right to Work in the UK
In accordance with the Immigration, Asylum and Nationality Act 2006, NHS National
Services Scotland has a legal obligation to ensure that it does not employ anyone who
has not been granted the relevant permission to work in the UK. We are therefore
required to check the entitlement to work in the UK of all prospective employees.
All shortlisted applicants will be asked to produce specific original documentation
plus a photocopy when attending interview.
Applications from candidates who require a Tier 2 Certificate of sponsorship will
only be considered if no suitable UK or EEA national is identified for this post.
NATIONAL SERVICES SCOTLAND
STAFF BENEFITS PACKAGE
Working for the NHS provides individuals with excellent career prospects and access to a wide range of
jobs. NHS National Services Scotland employs approximately 3,500 staff working in a number of
locations across Scotland.
Some of the benefits of working for NHS National Services Scotland are:
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A minimum of 27 days annual leave (pro rata) increasing with service
Eight public holidays (pro rata) per year
Access to flexible, family friendly working arrangements
Membership of the NHS Scotland superannuation scheme. Membership also includes a lump
sum death in service benefit.
Excellent training and development opportunities
Season Ticket Loan Scheme
Childcare Voucher Scheme
Cycle to Work Scheme
Access to national and local staff discounts and promotions
Occupational Health Service
Employee Counselling Service