Senior QC Analyst - Analytical

1w1 week ago

RoslinCT

Edinburgh, GB · Full-time · £40,000 – £55,000

About this role

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives. Collaborative, dedicated and talented people form the backbone of our culture, working autonomously and in driven teams with ground-breaking science. Join our Quality team as a Senior QC Analyst – Analytical in this shift-based position including evenings and weekends.

Lead and execute testing for clinical and commercial cell and gene therapy projects while supporting the QC-Analytical team to deliver QC data and projects. Oversee day-to-day laboratory operations ensuring adherence to cGMP, maintenance of QC systems, and operational excellence. Act as SME in QC assays including flow cytometry, viability, and aseptic cell culture.

Collaborate on GMP method transfer into QC laboratories and support training and mentoring of less experienced analysts. Execute GMP documentation workflows including Incident Reports, Change Controls, and Risk Assessments. Lead root cause analysis for investigations like OOS and Deviations, driving to closure within timelines.

Author, revise, and implement SOPs aligned with regulatory guidelines and write protocols to collect, analyse data, and compile reports. Support senior management in achieving company priorities and objectives. Deliver data and reports within expected timelines in a rapidly expanding company.

Requirements

At least 4 years’ experience working in a GMP Quality Control cell and gene therapy laboratory, ideally with 2 years in a Senior Analyst position
Experience in assay validation, stability testing, tissue culture, QC product testing and writing procedures to meet GMP and ICH guidelines
Experience in a variety of laboratory activities, with specialist knowledge of Flow Cytometry
Working knowledge of UK laws and regulations for cell therapy products and tissue donation
Excellent team working skills with ability to train, mentor and motivate junior team members
Excellent verbal communication skills with ability to effectively manage and influence stakeholders

Responsibilities

Lead and execute testing for clinical and commercial cell and gene therapy projects
Oversee day-to-day laboratory operations ensuring adherence to cGMP and maintenance of QC systems
Support training and mentoring of less experienced analysts
Collaborate for GMP method transfer into the QC laboratories
Act as SME in QC assays including flow cytometry, viability, and aseptic cell culture
Write and execute protocols, collect and analyse data, and compile reports
Author, revise, and implement SOPs in alignment with regulatory guidelines
Lead root cause analysis for investigations including OOS and Deviations