Senior GMP Production Manager
6 days left
- Full Time
The Centre for Cell and Gene Therapy (CCGT) manufactures ATMPs for a wide variety of novel gene and cell therapies for the treatment of cancers to rare diseases. This is an opportunity to work within one of the largest academic GMP facilities in Europe focusing on the delivery of gene therapy products for early phase clinical trials.
This role is for a Senior GMP Production Manager who has been working in the production department involved in the development and manufacturing of AAV vectors or other gene therapy products in an academic or industry-led GMP manufacturing facility and will report to Head of Production or, in his absence, CCGT Director. It is an opportunity to work with a world leading leading gene therapy group based at Guy’s and/or Denmark Hill campus on the delivery of AAV and Lenti viral gene therapy products for early phase clinical trials.
As part of the role profile, the post holder will possess sufficient previous experience as Production Manager in a Gene Therapy manufacturing GMP facility and be named as designated contact for Production Manager on the GMP License. The Production Manager should be able to manage a team of production and non-production staff and be capable of providing detailed daily instructions and explanations about the production activities of CCGT both orally and in writing to meet the milestones/objectives of the projects. Accordingly, they will be authoring production documents such as Manufacturing Records, Standard Operating Procedures, validation protocols and deviation reports. In addition to the core role, the postholder will take a leading and pro-active role in site start-up activities related to implementation of electronic quality documentation, facility and equipment qualification, GMP readiness and inspection of the AAV GMP manufacturing faciility, and if required, supporting manufacturing and release of gene therapy products within the GMP manufacturing facility at Denmark Hill. Further, the post holder is required to manage the process development team and support other development projects within the group, and will design and manage experiments in collaboration with other CCGT members, as required. In addition to hands-on supervision and training, they must be able to effectively communicate on compliance-related batch and regulatory documentation. As part of management role, they will ensure all tasks are risk assessed and performed consistently with a high level of confidence, clarity, concentration and integrity, including safe handling of different types of equipment, awareness and following of corresponding safety procedures, and in compliance with various regulatory requirements.
This post will be offered on a fixed-term contract for 48 months
This is a full-time post - 100% full time equivalent
- Solutions-focused self-starter, with excellent analytical, planning and organisational skills, able to manage staff, projects, and facilities, setting performance standards and establishing protocols to deliver these
- Lead and manage original and state of the art translational biomedical research and manufacturing as an integral member of CCGT, working on the development and release of cell and gene-based therapies for pre-clinical and clinical trials.
- Provide advanced expertise and management of a diverse team and resources to implement a range of cellular, molecular and bioprocess techniques to design, plan, optimise, develop, validate and execute approved batch manufacturing and quality procedures
- Compile Product Specification File (PSF) and Batch Manufacturing Record (BMR) for development and manufacturing operations of each product
- Lead on implementation of electronic quality documentation, and compile manufacturing and control specifications/results related to CMC documentation for generation of IMPD/IND
- Prepare and submit Gantt Chart for ‘Project & Quality Plan’ for approval by CCGT management and perform process development and manufacturing in accordance with periodically updated and approved PSF for manufacturing and release of products to clinical trial sites.
- Provide highly specialist advice and training to staff in development activities and hands-on quality operations related to aseptic techniques, cell culture, viral product harvest, purification, formulation and final product filling for cGMP compliance. Periodically review and approve the Training Matrix and staff training records for continued compliance of GMP qualification and maintenance activities, identifying and arranging relevant training and contribute to relevant meetings for continual professional development. .
- Manage, plan, develop and execute manufacturing and QC testing procedures as per approved BMR for GMP compliance and liaise with quality departments to meet the timely release of products for clinical trials
- Lead in the planning and execution of site start-up validation activities related to facility and equipment qualification, qualification procedures for cleaning and disinfection, environmental monitoring and decontamination operations
- Manage and lead staff in the scaling-up of manufacturing and purification processes and in the planning and execution of process development and validation activities, liaising with quality departments
- Proactively support the quality team in the development and execution of electronic quality assurance operations related to Pharmaceutical Quality System, electronic design history records and electronic supplier management system
- Manage and support staff for ensuring compliance of clean room preparation and quarantine procedures prior to after GMP manufacturing. Adhere to PQS and set high quality standards for service and execution to ensure GMP compliance.
- Periodically maintain, calibrate and validate relevant laboratory equipment.
- Actively identify and implement areas for development and improvement by proper execution of change control procedures. Review, manage and execute new technological approaches by incorporating quality risk management principles in all aspects
- Excellent spoken and written communication skills, with advanced computer use and strong interpersonal and influencing/behavioural skills to build a strong network to support the delivery of the service
- Maintain up-to-date, accurate and comprehensive laboratory records. Compile production and quality related documentation for review at quarterly quality management review meetings and internal/external audits (including regulatory GMP inspections).
- Prepare, review and approve laboratory reports related to execution and completion of all activities. Review and submit reports on results for verbal and multimedia presentations at regular GMP lab meetings, departmental seminars, national and international meetings.
- Review and actively contribute to the preparation of manuscripts for publication in peer review journals or book chapters.
- Analyse and interpret research data and draw conclusions on the outcomes.
- Ensure adequate analysis & implementation of development, manufacturing and testing objectives and proposals for execution of project timeline in accordance with approved project and quality plan
- Lead from the front and contribute actively to decisions affecting the work and performance of the team, representing the team at university and external meetings and deputising for CCGT management team where appropriate.
- Manage periodic staff meetings for ensuring GMP compliance and meeting goals/objectives of CCGT
- Forge relationships with colleagues and both internal and external stakeholders, to disseminate and get information, coordinate and deliver the required service and support the ongoing translational research programme.
- Manage and identify staff to lead interactions with external stakeholders including suppliers/ contractors and for research projects
- Effectively manage multiple projects and lead the team to track and manage progress and set project goals.
- Take decisions both independently and collaboratively in all areas of qualification, development, manufacturing, QC testing and certification.
- Continually update knowledge and understanding in field of cell and gene therapy.
- Translate knowledge of advances in the subject area into cost-effective, viable processes/technologies for development and GMP manufacturing.
- Supervise the research activities of undergraduate and postgraduate students engaged in process/analytical development
- Be responsible for the completion and revision of risk assessments, adapting the working environment to reduce the level of risk, including negative environmental impacts
- Demonstrate leadership and innovation in the implementation of environmentally sustainable practices, recording progress through the King’s sustainability audit process and sharing good practice. Nurture and encourage sustainable practices and leadership within your team and networks.
- Facilitate an inclusive culture and ethos working with academic, research and other professional services staff and colleagues external to King’s.
- Show consideration to others and be aware of and effectively manage the team, dealing tactically with any challenges affecting the achievement of CCGT objectives and deadlines, within the constraints and limitation of resources for GMP manufacturing and release in an academic organisation (when compared to industry).
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
A more comprehensive overview of the key responsibilities may be requested from Heather Kneale – firstname.lastname@example.org .
Skills, knowledge, and experience
1. Master’s degree in Biological and/or Engineering discipline related to life sciences or equivalent experience, with significant GMP training and substantial ATMP manufacturing experience (AP, I).
2. Strong background in bioprocess engineering, cellular and molecular techniques, and trained as designated site Production Manager for GMP manufacturing, leading to release of gene/cell therapy IMPs/ MS products in a licensed GMP facility in university or industry (AP, I)
3. Trained and managed team for process development, site readiness for GMP inspection, MCB/WCB development and certification, process validation, GMP manufacturing, certification and regulatory release, stability testing and delivering gene therapy products (preferably AAV or LV/RV) for pre-clinical and clinical trials (AP, I).
4. Comprehensive knowledge of regulations and best practice governing GMP manufacturing, including health & safety and environmental sustainability, and significant experience as a Production Manager in managing and ensuring compliance to Pharmaceutical Quality System in a GMP facility and actively contributing to supporting quality department and working closely with managerial roles in QA, QC & QP (AP, I).
5. Broad experience in managing and motivating team in handling aseptic techniques related to cell culture, product harvest, product purification, formulation and final product filling, in-process and quality control testing in a GMP facility (AP, I)
6. Substantial experience in managing and ensuring GMP compliance of environmental monitoring, clean room and equipment qualification, room quarantine and clearance for GMP manufacturing of gene therapy products for pre-clinical and clinical trials (AP, I).
7. Working knowledge of EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines, current MHRA Orange Guide including EU GMP regulations for ATMP manufacturing for clinical trials (AP, I)
8. Proficient in Project Management with delegation of staff responsibilities for manufacturing and release in a Gantt Chart for organisation of work load, excellent analytical, planning and organisations skills to ensure systematic and pragmatic approach to meeting objectives (AP, I).
9. Knowledge in compiling Batch Manufacturing Record and competent in managing and handling electronic or paper-based quality/batch documentation and records for IMPs/MS products (AP, I)
10. Competent in motivating and contributing to the team success by training colleagues, setting performance standards, providing scientific input during meetings, keeping a healthy working atmosphere in the development lab and GMP facility (AP, I).
11. Excellent spoken and written communications, strong interpersonal and influencing skills, ability to build strong networks internally and externally, excellent record keeping and attention to detail, (AP, I).
12. Competent in achieving and maintaining a strong work ethic, evidence of productivity and integrity at work (AP, I).
1. Significant experience in supporting quality and management team in implementation of electronic batch records and electronic quality documentation, particularly supplier management, document control, training records, validation including calibration and maintenance, audit, change control, deviations, CAPA, quality risk management (AP, I).
2. Substantial experience in manufacturing, certification and release of AAV gene therapy IMPs/MS products and approved for clinical trials (AP, I).
3. Broad experience in operation of production equipment for gene therapy (adherent/suspension technologies, cell disruption, chromatographic purification, concentration/diafiltration, final vial filling) and handling 3 or more AAV or other viral vector projects successfully from pre-clinical testing to batch manufacturing, CMC documentation and IMPD/IND approval (AP, I)
4. Experience in leading and motivating a team to meet agreed timelines for GMP batch manufacturing and release of gene therapy products for clinical trials (AP, I).
5. Able and willing to provide support beyond core hours, as required.