Job Summary
We are looking for GMP Production Scientist II to progress their career with us in the exciting area of cell and gene therapies.
You will work within the GMP manufacturing team to execute batch manufacturing of products supporting the delivery of Advanced Therapeutic medicinal Products (ATMP’s). The post holder will coordinate with Production Scientist, Cleanroom Technicians and Quality Assurance and Quality Control staff to facilitate the delivery of cellular therapy products for clinical use.
Company Information
Advent Bioservices is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the development of complex, breakthrough therapies for a globally diverse market. We are at the forefront of revolutionary medicine in which life-threatening diseases are treated using highly personalised therapies.
Responsibilities will include:
- Production of cellular therapies within a sterile environment, including cryopreservation and storage. This will include cell culture and raw material support in compliance with validated standard operating procedures (SOPs) and regulatory requirements.
- Conduct manufacturing activities as Support, Operator or Verifier, and ensure complete compliance with BMRs, SOPs and GMP Regulations.
- Assist senior staff in the organisation and supervision of daily GMP production housekeeping activities, including but not limited to cleaning, environmental monitoring, and stock management.
- Prepare technical reports and other clinical and GMP required documentation including but not limited to batch manufacturing records (BMRs), SOPs, Non-Conformances and Change Controls, working under the Quality Management System.
- Take a lead in the completion and management of Quality tasks assigned to the Production Team, including involvement in monthly production quality meetings and coaching and mentoring team members in writing quality documentation.
- Assist in training staff on GMP processes including environmental monitoring, GMP cleaning, and product manufacture.
- Support technical operations, process engineering and validation of cellular therapy products with full GMP compliance
- May perform line management of junior staff including supervision of training and completion of 1:1s.
- Subject matter expert for manufacturing related electronic systems (e.g. LIMS, EMS, eBMR).
You will have the following experience/qualifications:
- Proven practical experience in a GMP laboratory (GLP/GCLP/GMP) including aseptic manufacturing of cellular therapies in a controlled clean room environment
- BSc/MSc in a relevant science discipline
- Experience leading, supervising or coordinating teams and/or projects within a scientific, manufacturing or laboratory setting.
- Experience working within a quality management system, including the preparation, review and maintenance of quality.
- Working knowledge of GMP requirements applicable to ATMPs and regulations for cell and gene therapy products.
- Experience in contributing to Process Development within a laboratory environment
- Demonstrate adaptability and resilience by responding effectively to changing priorities, demands, and operational requirements.
- Flexible and collaborative approach with a willingness to undertake a variety of tasks to support departmental and organisational objectives.
- Acts with integrity and professionalism, maintaining confidentiality and taking ownership of responsibilities
- Strong organisational and time management skills with the ability to priorities workloads
- Effective communication skills, both written and verbal
- High level of accuracy and attention to detail with commitment to follow SOP’s
We are not accepting agency applications for this role
Candidates must be eligible to work in the UK
