Principal Scientist, Analytical Development

Orchard Therapeutics; London; On-site; GBP 70,000 - 100,000; Full time

Job summary

A leading global gene therapy company is seeking a Principal Scientist in Analytical Development to oversee late-stage projects, ensuring compliance with ICH and FDA regulations. The role involves designing validation strategies for analytical methods, contributing to regulatory submissions, and collaborating across teams to enhance product quality and safety. Candidates should possess a Ph.D. and significant experience in analytical development within the pharmaceutical industry.

Qualifications

• 7 years’ experience in analytical development in the pharmaceutical industry.
• Deep understanding of analytic techniques and regulatory compliance.
• Broad experience with regulatory authority inspections.

Responsibilities

• Implement project analytical strategy for late-stage development programs.
• Design analytical method validation strategies to support regulatory filings.
• Lead the development of breakthrough analytical techniques.

Skills

Analytical development

Regulatory submissions

Problem-solving

Communication

Data analysis

Education

Ph.D. in Biotechnologies, Life Sciences, or related field

Job description

Reporting to:Director of Advanced Analytics, Technical Development

Location:London

Job Summary

Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the life of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cell (HSC). Orchard has its global headquarters in London and U.S. headquarters in Boston.

The Technical Development (TD) organisation at Orchard is responsible for the development of manufacturing and analytical processes of Orchard’s HSC-based gene therapy pipeline which is actively collaborating with internal stakeholders and external CDMOs to develop innovative technical solutions to bridge early-stage, late-stage and commercial product needs.

The Principal Scientist, Analytical Development will be primarily responsible for delivering late stage analytical project milestones of specified Orchard development programs in close partnership with technical and regulatory functions within Orchard and at CDMOs. They will also be a member of the CMC team representing Analytics for the assigned project(s).

The incumbent will work together with innovator partners in process development as an integrated part of the development programs to provide scientific, technical support for advancing, de-risking and accelerating all stages of product development, including candidate selection.

The ideal candidate has demonstrated leadership and knowledge of the development, validation design and execution, implementation, maintenance and improvement of analytical methods as well as the delivery of high-quality regulatory submissions.

Responsibilities

• Implement defined project analytical strategy for the assigned Orchard’s late- stage development programs in close partnership with technical and regulatory functions at Orchard and CDMOs.
• Design analytical method validation strategies for Orchard’s programs in support of regulatory filings enabling strong analytical packages and robust control strategies ensuring product quality and compliance with applicable ICH guidelines and global health authority requirements and expectations.

• Lead the development of breakthrough analytical techniques aiming at achieving enhanced characterization, elucidate safety profile of gene therapies at cellular level and achieve advanced control over manufacturing consistency (e.g., first-in-class rapid assays, single cell analytics).
• Source, manage, and analyze large amounts of unstructured data via quantitative algorithms and statistical tools to address technical questions and drive program strategies.
• Serve as a subject matter expert, author and/or review relevant sections of CMC documentation in support of regulatory submissions, amendments as well as interactions with regulatory authorities.

• Proactively engage in collaboration with internal organisations (e.g. Research, Clinical Development and Operations, Quality, Manufacturing) and external stakeholders (e.g. CDMOs, contract testing labs) including health authorities and industry trade organizations to identify trends and expectations and incorporate them into Orchard’s analytical development and control strategies.

• Actively support inspection readiness activities and associated Health Authority Inspections; ensure quality, regulatory and EHS compliance.

• Qualify, validate and transfer analytical methods to ensure product quality and compliance with applicable ICH guidelines and FDA/EMA and other global health authority requirements and expectations; and provide technical input into selecting the most appropriate methodology, assay development and design.

• Support drug product characterization analysis and establishment of cellular gene therapy product CQA and markers that predict clinical efficacy and safety.

• Provide input into science-based, phase appropriate, and risk-based analytical validation strategy and specification setting to support clinical programs from pivotal phase to commercial registration and managed analytical assays for commercial products.

• Support the authoring and reviews of quality reports and documentation related to development, characterization and testing of analytical methods, as well as relevant sections of CMC documentation in support of regulatory submissions, dossier amendments as well as interactions with regulatory authorities.

Required knowledge

• 7 years’ experience in analytical development in the pharmaceutical industry
• Deep understanding of analytic techniques with a strong knowledge of the development, validation, implementation, analytical methods as well as the delivery of high-quality regulatory submissions
• Sophisticated knowledge and experience onstatistics-driven approaches and tools to quality and processunderstandingin thepharmaceuticalindustry
• Experience in late phase development of Cell and gene therapy, lentiviral vectors, hematopoietic stem cell biology and characterization and/or in vaccines/biologics characterization.
• Strong working knowledge and interpretation of FDA/EU and ICH regulations and guidelines.

• Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections

Skills & Abilities

• Demonstrated technical proficiency, scientific creativity, business acumen, collaboration with others, independent thought and learning agility
• Able to deliver high quality regulatory submissions
• Effective communicator and influencer with proven ability to build relationships internally and externally to the organization that enable strong collaboration between all key stakeholders to achieve critical milestones
• Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
• Excellent problem-solving skills and organizational skills
• Seeks and analyzes data from a variety of sources to support decisions and align others
• Comfortable with ambiguity and uncertainty; able to make decisions through complex situations
• Creates collaborative and trusting relationships internally and with external partners

Education

• Ph.D. in Biotechnologies, Life Sciences, or related field with strong expertise in advanced analytics and data science applied to the development of cell and gene therapies