Reporting to:Senior Manager DS/DP MSAT
Location:London
Job Summary
This role, within the Manufacturing Sciences and Technologies (MSAT) is pivotal in ensuring seamless communication and operational manufacturing readiness between Orchard Internal functions (MSAT, Supply Chain, GMP QA) and Orchard CDMO partner(s). This position will report into the head of DS/DP MSAT and will also have responsibilities with the head of Vector MSAT. The role holder will be responsible for managing, coordinating and leading manufacturing documentation technical reviews and approvals, in collaboration with relevant SME’s, for both Viral Vectors and Drug Products, ensuring accurate and cohesive translation of the technical control strategy documents into manufacturing and/or production documentation (batch records, sampling plans, testing strategies). In addition, the role holder will manage and coordinate technical reviews of manufacturing deviations, changes or other quality events related to manufacturing activities as required. The incumbent with strong knowledge of manufacturing processes and excellent scientific background in CGT will support MSAT DS/DP and LVV technical leads for Continued Process Verification (CPV) efforts through data collection, structural organisation and trend analysis for commercial program and will establish initial manufacturing data collection and repository for late-stage program transition into MSAT ensuring data integrity is maintained throughout the process.
The successful candidate will be a highly motivated, detail-oriented, organized MSAT scientist. The individual will have relevant experience in Cell Gene Therapy products particularly in viral vector and/or cellular therapies products. Experience in experimental study design, statistical data and trend analysis is essential.
The post-holder will have a good understanding of GMP, statistical methods, QbD approaches and quality control of data, with excellent attention to detail, communication, presentation, and organizational skills, effective troubleshooting ability, and the ability to work independently and as part of a team.
Key Responsibilities
· Liaison and coordination for manufacturing readiness:
o MSAT point of contact between internal teams and CDMO to ensure manufacturing readiness
o Facilitate planning of manufacturing documentation updates in-line with production schedule and requirements
o Participate in weekly manufacturing internal meeting and regular meetings with CDMO
o Coordinate timely delivery of manufacturing documentation in-line with Manufacturing schedule
o Manage and coordinate technical review of manufacturing deviation, changes or other quality events related to manufacturing activities and ensure proper escalations and documentation resolution
o Review manufacturing documentation and ensure alignment with current process description and control strategy
· Process Data Analyst:
o Support CPV efforts by ensuring accurate and timely data collection from manufacturing processes
o Owner of the data bases design, maintenance and structural organisation
o Actively contribute to development of manufacturing database and tools
o Support statistical analysis on manufacturing data to identify trends, variability and opportunities for process improvement
o Actively contribute to Trending meetings or committees
o Generate reports and visual supports as needed
o Maintain data integrity and ensure compliance with data management as per internal SOP and in accordance with regulations.
Requirements
Required knowledge
· Experience in Cell and Gene Therapy in one or more of the following areas: lentiviral vectors, plasmids & cell banks, haematopoietic stem cell biology
· Experience working with CDMO and/or third parties
· Good knowledge of GMP
· Good knowledge and understanding of the QbD principles
Skills & Abilities
· Sound scientific and technical proficiency
· Trouble-shooter, problem solver mentality
· Excellent communicator
· Effective collaborator able to build strong relationships with both internal and external stakeholders
· Action oriented
· Ability to operate in a fast-paced, multi-disciplinary industrial environment.
Education and Experience
· At minimum, a BSc. in a relevant scientific discipline, such as Chemistry, Biochemistry, Molecular Biology, Cell Biology, Chemical Engineering, or another relevant field,
· Relevant experience in the biotechnology or pharma industry within a MSAT, production or process development function
