The GMP Production Scientist will be part of the GMP manufacturing team, responsible for performing batch manufacturing of contract manufacturing products. This role supports the delivery of Advanced Therapeutic Medicinal Products (ATMPs) as both "Specials" and Investigational Medicinal Products (IMPs). The post holder will collaborate with other Production Scientists, Manufacturing Laboratory Assistants, and Quality Assurance/Control staff to efficiently deliver cellular therapy products for clinical use.
Principal Accountabilities
Production of Cellular Therapies:
Work within a sterile environment.
Perform tasks such as cryopreservation and storage.
Conduct cell culture and raw material support following validated standard operating procedures (SOPs) and regulatory requirements.
Quality Control (QC) Assays:
Conduct QC assays for product release using techniques like flow cytometry, ELISA, ELISPOT assays, microscopy, cell culture, and SDS electrophoresis.
Documentation:
Prepare technical reports and GMP-required documentation, including batch manufacturing records (BMRs), SOPs, equipment validation, and deviation reports, adhering to the Quality Management System.
Process Engineering and Validation:
Support the process engineering and validation of cellular therapy products for successful technology transfer into the facilities with full GMP compliance.
Equipment Validation:
Plan and undertake the validation of new equipment used in GMP manufacturing.
Manufacturing Activities:
Conduct manufacturing activities as an Operator or Support, ensuring complete compliance with SOPs and GMP regulations.
GMP Housekeeping and Administration:
Undertake daily GMP production housekeeping activities and administration, including cleaning, environmental monitoring, stock control, ordering materials, and managing suppliers.
Product Handling:
Assist in the labelling, packaging, storage, and shipping of cellular therapy products, and maintain product inventory.
Person Specification
Qualifications/Knowledge/Experience:
Minimum 2 years practical experience in a biomedical/GMP laboratory (Essential)
BSc in a relevant science (Essential)
Experience with cell culture techniques (Essential)
Experience in aseptic manufacturing of cellular therapies in a controlled clean-room environment (Desirable)
Working knowledge of GMP for ATMPs and regulations for cell and gene therapy products (Essential)
Experience working within a quality management system (Desirable)
Experience with viral vector production and purification, and gene therapy manufacture (Desirable)
Ability to interpret anomalous process or test results and propose explanations or rectifying approaches (Desirable)
Personal Skills & Key Competencies:
Excellent written and verbal communication skills (Essential)
Proactive, flexible, and meticulous approach to work (Essential)
Strong team player (Desirable)
Excellent IT skills (Essential)