Jobs

Immetacyte Limited - Senior GMP Cell Therapy Technician

Job Title:
Senior GMP Cell Therapy Technician
Category:
Technical roles
Closing Date:
28/02/2020

Location: Manchester, UK

Position reports to: GMP Production Manager

Competitive Salary and Benefits Package

Application Deadline: 28th February 2020

About the Company:

Immetacyte Ltd is focused on developing patient specific immunotherapy, allowing the patient’s own immune system to be harnessed in order to fight cancers. Specifically, Immetacyte is developing adoptive cell therapy (ACT) and has expertise in manufacturing and engineering of cells in a GMP compliant manner ready for patient infusion. The company has a track record of developing cell therapies with clinical success. Immetacyte is beginning clinical trials in its autologous cell therapy product Tumour Infiltrating Lymphocytes (TIL).

The Opportunity:

We are therefore pleased to offer an excellent opportunity to join this early stage SME at a dynamic and exciting time in the evolution of the company. We are seeking to appoint a diligent, enthusiastic and motivated individual to the following post.

The Key Tasks detailed within this Job Description are not intended to represent an exhaustive list of the duties that the job holder may be required to undertake and where reasonable the employer may from time to time ask for activities in addition to this job role.

A key part of the role is to perform GMP cell culture and the associated GxP assays within the laboratory, clean room or aseptic isolator to ensure the safe manufacture of medicinal products for human use

GMP Production

  • To perform GMP production of the aseptically manufactured cell products and the associated GxP assays
  • To perform, where required, the recording of any incidents related to production with the aim to minimise impact and consistently manufacture of the products to the GMP standards and specfications
  • To participate in the creation & the review of the technical documentation (BMR’s, SOPs, FRM’s, DAT’s etc.) as part of the CTU quality system as requested by the Production Manager
  • To perform or participate in various process validation activities as requested by the Production Manager

Materials & Consumables

  • Ensuring the availability of sufficient consumables and reagents stock to enable the manufacture of CTU products
  • Good communication with suppliers and where necessary sourcing new consumables as required
  • Sourcing and recommending consumables and reagents that meet the agreed specifications of the PSF from approved suppliers to the Production and Quality managers
  • Assist & participate in the assessment of external GMP and associated supplier activities, facilities and materials to ensure they meet the Quality Management System policies and associated product specification as authorised by the Production & Quality Manager

Training

  • To undertake training activities as required by the Production manager in order to ensure GMP activities and the release of Medicinal products are performed and documented according to the Quality Management System and associated Training policies
  • To ensure that training activities are recorded, and the records are routinely kept up to date
  • To participate at any relevant internal or external training that would benefit personal performance within the assigned role at the company

General activity

  • Routine operational testing of laboratory equipment as part of production activities
  • Ensuring the critical samples are safely delivered to external testing facilities as part of production activities
  • Appropriate regular facility cleaning, monitoring and disposal of waste

Quality Management

  • To operate within the active policies, procedures and SOPs defined within Immetacyte Quality Management System
  • Involvement role in the qualification and testing activities as part of the change control process where required by the Production and Quality managers
  • Participation in incident reporting, investigations, root cause analysis and CAPA where required by the Production and Quality managers
  • Under the guidance of Quality and Production manager develop and implement the process required to enable the selection and approval of replacement or alternative reagents & materials within the requirements of the QMS procedures.

Safety activities

  • Comply with all site Health and Safety Regulations
  • Be aware of and follow the Health & Safety Agenda and work to the associated COSHH and Risk Assessments

Essential Requirements:

  • At least 1-2 years GMP production experience in the Bio-industry
  • Knowledge of a range of research techniques and methodologies
  • Excellent communication skills – written and oral
  • Ability to work well with others in a team environment
  • Willingness to learn and apply new techniques
  • Ability to plan and prioritise own work and teamwork in order to meet deadlines
  • Experience in implementation of change programmes
  • Experience and ability to use initiative in planning and performing general lab duties

Desirable Skills:

  • BSc in Immunology, Molecular Biology or related discipline
  • Professional Registration in an appropriate subject area
  • Excellent tissue culture technique
  • Experience in flow cytometry, molecular biology and gene transfer techniques
  • Knowledge of cell therapy, molecular biology and bioassay development related to cell function
  • Knowledge and experience of molecular biology techniques relevant to adoptive cell therapy research
  • Closed system manufacturing experience
  • Experience of assisting in the design and adoption of new GMP compliant processes
  • Knowledge of the immunotherapy field
  • Understanding of the role of the MHRA, HTA and H&SE in Good Manufacturing Practice

Application Process: 
Please send a CV and a detailed covering letter to careers@immetacyte.com or to the address below.
 
HR
Immetacyte Ltd
48 Grafton Street
Manchester
M13 9XX
 
 

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