Career Opportunities in the Foresite Capital Network

Reporting to: Head of Analytical and Manufacturing Sciences and Technologies (A-MSAT)

Location: London

Job Summary

The successful candidate will be responsible for leading thelate-phaseAnalytical Sciences team and will oversee the qualification/validation and deployment of all analytical methods and ensure the implementation of effective control strategies and assessment of CQAs in support of product lifecycle management.

The individual will have relevant experience in Cell Gene Therapy products particularly in viral vector and cell therapies.

The post-holder will be a key member of the MSAT leadership team and will strategize phase appropriate management of all product test methods in-line with program and company plans and will work collaboratively with both internal and external stakeholders to ensure timely and robust implementation of appropriate product quality attribute strategies as well as represent Orchard in regulatory inspections and discussions.

Key Responsibilities

• Head the Analytical Sciences team within the MSAT organization to qualify, validate, deploy and manage analytical methods to ensure product quality and compliance with applicable ICH guidelines and FDA/EMA and other global health authority requirements and expectations
• Oversee drug product characterization analysis and establishment of cellular gene therapy product CQA and markers that predict clinical efficacy and safety
• Proactively engage in collaboration with internal and external stakeholders and industry trade organizations to identify trends and expectations and incorporate them into Orchard’s analytical control strategies
• Lead 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
• Lead, oversee and/or author high quality reports and documentation related to analytical methods
• Serve as a subject matter expert, author and/or review relevant sections of CMC documentation in support of regulatory submissions, dossier amendments as well as interactions with regulatory authorities
• Work with CDMOs, contract testing labs and Internal teams to drive continuous improvement of control strategy, analytical methods and product quality
• Actively support inspection readiness activities and associated Health Authority Inspections
• Develop, maintain and implement internal and external processes to meet regulatory requirements
• Support development, implementation, and execution of a technology roadmap in-line with Orchard’s manufacturing strategy
• Ensure internal and external capabilities, skills, and capacities meet Orchard’s requirements and drive acceleration of robust pipeline progression with clear understanding of risk and trade offs
• Ensure quality, regulatory and EHS compliance
• Pro-actively interface with Process Development, Clinical Development and Operations, Quality, Manufacturing and CMC
• Instill scientific rigor and enhance process knowledge across the team
• Manage and oversee all aspects of team performance and development

Required knowledge

• Comprehensive knowledge with the qualification, validation, implementation, trending of assay performance, maintenance and improvement of analytical methods
• Proven experience of the delivery of high-quality regulatory submissions
• Experience in managing third party laboratories executing assay qualification and validation, assay technology transfer, and comparability studies
• Proven experience in leading a team of analytical development scientists and working in partnership with MSAT team to deliver appropriate control strategies
• 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. Candidate with comprehensive experience of vaccines/biologics characterization will be considered.
• Excellent working knowledge and interpretation of FDA/EU and ICH regulations and guidelines
• Broad and/or direct experience with regulatory authority inspections, including both FDA and EMA inspections

Skills & Abilities

• Demonstrated technical proficiency, scientific creativity, collaboration with others, independent thought and learning agility
• Make sound decisions regarding complex technical issues and communicates decisions effectively with internal and external stakeholders, elevating complex issues as appropriate
• An individual who is self-reflective and leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement
• Create collaborative and trusting relationships internally and with external partners
• Strong verbal, presentation, and written communication skills. Can concisely articulate and deliver effective presentations on complex technical issues
• Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
• Excellent problem-solving skills as well as time management and organizational skills

Education

• MSc PhD in a relevant scientific discipline such as Chemistry, Biochemistry, Molecular Biology, Cell Biology, Chemical Engineering, or another relevant field