Senior Manufacturing Scientist for Cell and Gene Therapy

4 days ago

London, Greater London, United Kingdom Orchard Therapeutics Full time
Job Description:

We are seeking a highly motivated Senior Manufacturing Scientist to join our team at Orchard Therapeutics. This is an exciting opportunity to contribute to the development of innovative cell and gene therapies.

About the Role:

The successful candidate will be responsible for managing, coordinating, and leading manufacturing documentation technical reviews and approvals, in collaboration with relevant SMEs. This includes ensuring accurate and cohesive translation of the technical control strategy documents into manufacturing and/or production documentation. Additionally, the role holder will manage and coordinate technical reviews of manufacturing deviations, changes, or other quality events related to manufacturing activities as required.

This position will also support Continued Process Verification (CPV) efforts through data collection, structural organisation, and trend analysis for commercial programs. The incumbent will establish initial manufacturing data collection and repository for late-stage program transition into MSAT, ensuring data integrity is maintained throughout the process.

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
  • Process Data Analyst:
    • Support CPV efforts by ensuring accurate and timely data collection from manufacturing processes
    • Owner of the databases 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:

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 is preferred.

Experience in Cell and Gene Therapy in one or more of the following areas: lentiviral vectors, plasmids & cell banks, haematopoietic stem cell biology is desirable. Good knowledge of GMP and understanding of QbD principles is also essential.

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, and ability to operate in a fast-paced, multi-disciplinary industrial environment are necessary skills.

Estimated Salary:

£65,000 - £85,000 per annum, depending on experience.

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