Senior Scientist, MSAT

2 weeks ago

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

Orchard Therapeutics, a leading gene therapy company, is seeking a highly experienced Senior Scientist to join its Manufacturing Sciences and Analytical Technologies (MSAT) team. As a key member of the team, you will be responsible for supporting the late-phase DS/DP MSAT team and process development, validation, and maintenance of all DS/DP manufacturing processes.

Key Responsibilities
  • Serve as a subject matter expert for commercial GMP manufacture and testing of Drug Substance (DS) and Drug Product (DP) at Contract Development and Manufacturing Organizations (CDMOs).
  • Provide expert compilation, review, and approval of relevant documentation, including master production records, standard operating procedures, and quality documentation.
  • Support technical transfer of commercial DS/DP process manufacture within GMP and to future CDMOs, ensuring PPQ and validation status of products are maintained in line with applicable ICH, EMA, FDA, or other health authority guidance.
  • Support drug product characterization analysis and establishment of cellular gene therapy product CQA and markers that predict clinical efficacy and safety.
  • Engage in collaborations with internal and external stakeholders to identify trends and expectations and incorporate them into Orchard's DS DP control strategies.
  • Collect, assemble, analyze, and summarize production data post PPQ using appropriate statistical methods for Continued Process Verification (CPV).
Requirements
  • Experience in Cell and Gene Therapy in one or more of the following areas: lentiviral vectors, plasmids, cell banks, haematopoietic stem cell biology, and characterization.
  • Strong experience with risk-based approaches, such as Failure Modes and Effects Analysis.
  • Proven track record of using Quality management systems, change management, deviations, and quality events.
  • Experience in working with third-party laboratories executing assay technology transfers and testing.
  • Experience in defining and planning comparability studies.
  • Experience of helping with the compilation of high-quality regulatory submissions.
  • Experience of regulatory authority inspections, including FDA and/or EMA inspections.
  • Working knowledge and interpretation of FDA/EU, GMP, and ICH regulations and guidelines.
  • Knowledge of QbD principles and application.
  • Understanding of the Product Life Cycle, with reference to industry standards and guidelines.
Skills and Abilities
  • Sound scientific and technical proficiency with an awareness of developments in novel technologies within the industry.
  • Ability to make reasoned decisions regarding complex technical issues and communicate them effectively.
  • Strong verbal, presentation, and written communication skills.
  • Ability to think critically and 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.
  • Extensive experience in the biopharmaceutical industry executing process validation activities or process development.

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