Advanced Therapy Production Scientist
2 months ago
Job summary
The position on offer allows the applicant a unique opportunity to become involved in cutting edge translational research at the interface between science and clinical medicine.
The post holder will be responsible for the technical transfer, scale up, engineering and production of therapies within the BRC GMP Unit.
The position includes taking responsibility for developing and implementing independently: Product Specification Files (PSFs), Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs) for Production activities of the GMP unit.
The post holder will work independently making informed decisions relating to manufacturing activities as delegated by the Head of Advanced Therapy Production tocreate procedures to ensure compliance with government legislation and trust requirements.
The post holder will ensure that all products are manufactured and stored according to appropriate rules and guidelines helping to ensure products are fit for their intended use with respect to safety and quality by undertaking specialist tests to maintain quality standards whilst in production.
Main duties of the job
Key responsibilities:
Assist in the manufacturing of Investigational Medicinal Products (IMP) for clinical trials and or Specials Products Ensure by working with the Head of Production that production of clinical trial products meet on time in full targets Qualify and validate production methods involving: closed cell processing; primary cell culture; cell isolation; and cell proliferation. Work collaboratively with collaborators to undertake technical transfer, and qualification of production processes within the GMP unit for regulatory authorisation. Work as part of a team maintaining the GMP facilities and equipment in accordance with maintenance and validation programmes. Operate within and contribute to a GMP Pharmaceutical Quality System including change control, preventive actions, deviation management and document control.Therefore, this post requires someone with good attention to detail, a quick learner, flexible, able to work under changing landscapes and has strong communication and interpersonal skills with a positive can-do attitude.
About us
The Advanced therapies Manufacturing Platform is co-located with the Clinical Research Facility (CRF) at Guy's Hospital on the 15th floor of the tower. The GMP Unit is purpose built for the manufacture of Advanced Therapy Medicinal Products such as somatic cell therapies, gene therapies and tissue engineered products for early-phase clinical trials. It is used for both commercial and non-commercial clients as well as departments within GSTT and KCL to manufacture products related to trials undertaken in the CRF and at trial sites across the UK.
Job description
Job responsibilities
Please see the Job Description and Person Specification for detailed information regarding the responsibilities and requirements for this post.
Person Specification
Skills
Essential
Cell culture experience
Desirable
Experience in Cell Isolation ( T cells/B cells/NK cells)
Experience
Essential
Understanding of medicines manufacture
Desirable
Experience of working in a GxP environment
Knowledge/Qualifications
Essential
Bsc In Biochemistry/Immunology or related discipline
Desirable
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