Job Description
We have an exciting opportunity for a high caliber Senior Production Scientist with a strong background in Good Manufacturing Practice (GMP) of medicinal products, to join a growing organisation, providing GMP manufacturing services and process development, for novel cell and gene therapy products. This is a fantastic opportunity for an enthusiastic, driven and experienced Scientist wanting to contribute to the shaping of a growing department, committed to delivering the best service for the advancement of Cell Therapy products - from the benchtop to the bedside, making a difference to patients.
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.
Job Summary
Based on-site in Sawston, Cambridge, the Senior Production Scientist will be responsible for leading, managing and training a team of scientists to support the technology transfer, validation and clinical production of therapeutics for ATMPs within GMP clean rooms. The Senior Production Scientist will lead improvements in scientific practice, working continually to improve standards.
The successful candidate will supervise and lead GMP production (and production staff), formulation and banking of cellular therapy products, including cell culture and raw material support, in compliance with validated standard operating procedures (SOPs) and regulatory requirements. This role will also have accountability for the accurate completion of batch documentation to GMP standards, including the interpretation, analysis, and reporting of results. This role will also be responsible for coordinating activities, with the QC department, to ensure efficient sampling and testing of raw materials, in process controls and final drug product.
You will have the following experience/qualifications:
- Experience in a Senior Scientist leadership position, ideally within a GMP environment
- Experience of line managing, training and mentoring staff.
- BSs/MSc in Biological Science or related Life Science
- Working knowledge of GMP for ATMPs and regulations for cell and gene therapy products.
- Demonstrable knowledge of regulatory compliance including MHRA licensing requirements
- Experience working within a quality management system
- Knowledge of QC reporting and testing and packaging of ATMPs
- Strong organisational skills and the ability to prioritise and work under pressure
With our newly built and accredited facility in Sawston and new build projects on the horizon, this is a fantastic opportunity to join the team and establish yourself as a key team member.
We offer an attractive base salary and benefits package.
Job Type: Full-time