Senior Production Scientist

Job summary

The position on offer allows the applicant an opportunity to become involved in cutting edge translational research at the interface between science and clinical medicine and is a reflection of bench to bedside concept.Working under the trusts Pharmaceutical Quality System, the post holder will use their experience and specialist knowledge in Good Manufacturing Practice (GMP), immune cell culture, immune cell purification by high end multicolour flow Cytometry and or other methods to take responsibility for developing and delivering the manufacturing process for novel cutting edge clinical trial studies. Also, a significant attribute of this job would be to supervise a team of production scientists.

Main duties of the job

Senior Advanced Therapies Production Scientist, Advanced Therapy Manufacturing Platform -NIHR Guy's Hospital

Key responsibilities:

Lead and supervise production scientists in the batch manufacture of IMP/Specials under the centre's license Lead and supervise staff in the validation of equipment's and processes as per local procedures Lead as a scientific expert for technology transfer of new projects Lead and supervise staff in process development/improvement activities Ensure by working with the Head of Production that production of clinical trial products meet on time in full targets Ensure with Head of Production planned maintenance work schedule is followed and suggest system improvements Supervise Production Scientists and actively assist them with their workload

Therefore, this post requires someone with good attention to detail, a quick learner, flexible, able to work under changing landscapes and has strong communication skills with a positive can-do attitude.

About us

The Advanced Therapies Manufacturing Unit (ATU) is co-located with the Clinical Research Facility (CRF) at Guy's Hospital on the 15th floor of the tower. The ATU 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 or as Specials. It is used for both commercial and non-commercial collaborators as well as departments within GSTFT and KCL to manufacture ATMPs related to trials undertaken in the CRF and at trial sites across the UK.

Job description

Job responsibilities

4. Duties and Professional / Clinical Responsibilities Responsible for delivering a highly specialist clinical technical service by leading in the manufacturing of immune cell therapy products for the clinical needs of participants on current and future clinical trials or Specials. Assess the suitability of human cells received for manufacture and liaise with senior clinical staff for action or advice if unsuitable. Ensure the correct disposal of cells and/or patient samples in accordance with relevant departmental and governmental policies. Ensure that manufactured products are labelled, documented and stored according to authorised specifications and quality standards. Responsible for maintaining an up-to-date knowledge-base of Immunological products used in Adoptive Cellular Therapy while demonstrating advanced competencies through a personalised Continued Professional Development portfolio. Capable of working independently and as part of a team of clinicians, scientists and regulatory personnel. Required to work with users of the BRC Advanced Therapies Manufacturing Unit to develop multicolour phenotyping panels for FACS profiles to allow cell selection and subsequent cell expansion. Required to work with collaborators in developing processes by taking pre-clinical ideas and technology transferring to the unit and ensuring phase appropriate GMP compliance Lead Validation and qualification procedures for processes and equipments used for manufacture of immune cell products3 Provide specialist knowledge of the latest developments within cell and gene therapy manufacturing science and technology Provide specialist knowledge of Immunology of human cells and suggesting continuous process improvement ideas Report result outcomes and provide specialist advice to clinicians, investigators and scientists in clinical development. Take responsibility for developing and implementing independently controlled documents: Investigational Medicinal Product Dossiers, Product Specification Files, Batch Manufacturing Records and Standard Operating Procedures (SOPs) for Production activities in the GMP unit. Ensure adequate maintenance and supervision of equipment, and ensure compliance with Planned Preventive Maintenance (PPM) Undertake strategic judgements based upon specialist knowledge of the manufacturing process, operating within the boundaries of the Pharmaceutical Quality Systems (PQS) Qualify, validate and re-validate equipment and GMP procedures successfully and on-schedule according to the Units Validation Master Plan (VMP) and PQS Hands-on experience operating in an aseptic GMP Unit manufacturing ATMPs will provide you with the skills to meet these developing needs. Be proficient in advanced scientific data analysis. Knowledge of specialist scientific software R, Flow Jo, Graphpad Prism is desirable Show advanced level knowledge of Immunology in the context of cell activation, growth , functionality and potency of immune Management and Leadership Responsibilities Communicate with colleagues about specialist complex manufacturing procedures, you will bring innovation and development to the role, ensuring that the service provided by the Unit remains world-leading. Disseminate research and specialist technical knowledge. Attend and lead in presenting at BRC meetings, seminars and national or international meetings where deemed appropriate. Plan and prioritise the use of specialist GMP equipment workload, liaising with other departments, and suppliers in relation to manufacturing ATMPs. Interact with the Units capacity planning system to ensure the smooth running of the Unit. Work unsupervised managing production deviations, making informed decisions relating quality systems. Provide day-to-day professional supervision and practical training for production activities and ongoing supervision of support staff, and new and junior staff. When required /able to act as the Deputy for the Production Manager supervising Production staff members, and managing Production schedules. Good communications skills , being able to work with different stakeholders and their project specific needs4 Can-do attitude, flexibility and pragmatic approaches to problem solving is Quality Responsibilities Operate within the Pharmaceutical Quality System: Have an understanding of PQS tools such as Deviation/Change management additionally an understanding of risk assessments is required. Where directed or delegated by the Head of Advanced Therapy Quality, you will help develop specific, accurate, precise and robust specialist Quality Control assays to be used following immune cell therapy production. Assist in the management and monitoring of Quality Assurance and Quality Control activities, ensuring that agreed quality standards of service are Documentation Responsibilities:Using your specialist knowledge you will undertake the development and generation of: Unit-specific SOPs and policies relating to and manufacturing operations. These must comply with GMP and the Units manufacturing licence. Product-specific SOPs and batch-specific documentation for the manufacture of ATMPs. Product Specification Files or Preparation Process Dossiers and or IMPDs for cell Information Management Responsibilities Play a major role in generating data for the application to the regulatory authorities for Clinical Trial Authorisation (CTA). You will record meticulously all data generated for the CTA submission to GMP standards. Work in compliance with national standards for the safe, secure and confidential processing and storage of patient and laboratory information and when accessing patient information on computer databases. You will be active interpreting data, and participate in writings for Working Conditions:The role calls for a detail-orientated and highly-motivated individual with the ability develop ex-vivo immune cell culture protocols using specialist data analysis tools. Prolonged concentration is required when processing samples, and operating specialist manufacturing equipment. There will be prolonged work in a clean room. There will be occasional moderate physical effort requirement for sitting and standing in a restricted position for a substantial proportion of time working in Grade A Isolator systems. There will be sitting and standing daily for bench work for long periods, with frequent repetitive movements. You will need excellent highly developed physical skills where accuracy is important; hand-eye co-ordination and accuracy for processing material as well as excellent dexterity for the fine adjustments to specialist Exposure to distressing or emotional circumstances is rare but may occur, with limited patient contact.

Person Specification

Qualification

Essential

Masters/Phd in Biological Sciences preferably in Immunology Experience of ATIMP manufacturing in an academic or industrial setting Degree equivalent and 3+ years' experience in the manufacture of ATIMPs or stem cell products

Personal Characteristics

Essential

Strong Can do and positive attitude Able to work flexibly over weekday or weekend Good Interpersonal skills along with pragmatic view of workings of the unit and understanding the need for flexibility High level of work organisation, selfmotivated and autonomous with strong professional integrity Ability to learn new concepts and scientific ideas

Skills

Essential

Meticulous attention to detail Experience of DoE for process development Ability to work within a multidisciplinary and diverse team Ability to follow written or verbal instructions Ability to work under pressure and changing landscape Good MS Office skills Word/PowerPoint and Excel

Experience

Essential

Hands on experience of functionally closed system cell culture of primary human cells ( Closed system Bioreactors for cell culture) Hands of experience of isolation of primary human cells ( magnetic cell separation or FACS) Knowledge of EU-GMP/US-FDA and expectations for ATIMP's Experience of supervising small teams

Desirable

Experience of different functionally closed cell transduction techniques Experience of performing feasibility assessment of new functionally closed system /equipment Experience of developing and qualifying ATIMP's from pre-clinical ideas upto CTA submission Experience of equipment /process validation Experience in process development , developing CQA/CPPs for ATIMPs Extensive experience of batch manufacture of ATIMPs and Specials Experience of budgeting and forecasting Experience of DoE for process development

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