Scientist, MSAT Specialist

6 days ago

London, Greater London, United Kingdom Orchard Therapeutics Full time
Job Summary

This role is pivotal in ensuring seamless communication and operational manufacturing readiness between internal functions and CDMO partners. The position will report into the head of DS/DP MSAT and will also have responsibilities with the head of Vector MSAT.

Key Responsibilities
  • Liaison and coordination for manufacturing readiness:
    • MSAT point of contact between internal teams and CDMO to ensure manufacturing readiness
    • Facilitate planning of manufacturing documentation updates in-line with production schedule and requirements
    • Participate in weekly manufacturing internal meeting and regular meetings with CDMO
    • Coordinate timely delivery of manufacturing documentation in-line with Manufacturing schedule
    • Manage and coordinate technical review of manufacturing deviation, changes or other quality events related to manufacturing activities and ensure proper escalations and documentation resolution
    • Review manufacturing documentation and ensure alignment with current process description and control strategy
  • Process Data Analyst:
    • Support CPV efforts by ensuring accurate and timely data collection from manufacturing processes
    • Owner of the data bases design, maintenance and structural organisation
    • Actively contribute to development of manufacturing database and tools
    • Support statistical analysis on manufacturing data to identify trends, variability and opportunities for process improvement
    • Actively contribute to Trending meetings or committees
    • Generate reports and visual supports as needed
    • Maintain data integrity and ensure compliance with data management as per internal SOP and in accordance with regulations
Requirements

· 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

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