Senior Scientist, MSAT

Orchard Therapeutics; London; On-site; GBP 60,000 - 90,000; Full time

Job summary

A leading company in gene therapies seeks a Senior Scientist to support the Drug Substance/Drug Product Manufacturing Sciences team. The role involves overseeing GMP processes, managing product lifecycle activities, and ensuring compliance with industry standards. Candidates should have expertise in Cell Gene Therapy and associated regulatory knowledge, with relevant educational qualifications in the sciences.

Qualifications

• Extensive experience in process validation or process development in the biopharmaceutical industry.
• Experience with risk-based approaches like FMEA and quality management systems.
• Knowledge of regulatory submissions and GMP guidelines.

Responsibilities

• Oversee commercial GMP manufacture and testing of DS and DP.
• Support technical transfer of DS/DP processes within GMP.
• Lead in process development and validation strategies for clinical programs.

Skills

Cell and Gene Therapy

Statistical methods

Quality control

Analytical skills

Critical thinking

Education

BSc. in Chemistry

Higher education qualifications in relevant science or engineering disciplines

Job description

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Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, is looking for a dynamic and experienced Senior Scientist in the Drug Substance (DS)/Drug Product (DP) Manufacturing Sciences & Analytical Technologies (MSAT) team.

The successful candidate will be responsible for supporting the late-phase DS/DP MSAT team and late-phase process development, validation (as required), and the maintenance of all DS/DP manufacturing processes to ensure the implementation of effective control strategies and assessment of CQAs in support of product lifecycle management.

The post holder is a key member of the MSAT team and will implement phase-appropriate management of all product manufacturing processes in line with program plans, company objectives, and health authority expectations. They will work collaboratively with internal and external stakeholders to ensure timely and robust process controls and will represent DS DP MSAT with Orchard cross-functional teams and CDMO cross-functional teams. Relevant experience in Cell Gene Therapy products, particularly in viral vectors and cell therapies, is essential.

The candidate should have a comprehensive understanding of GMP, statistical methods, and quality control of data, with excellent attention to detail, communication, presentation, organizational skills, troubleshooting abilities, and the capacity to work independently and within a team. Knowledge of microbiological control strategies or chemistry, including leachable & extractables, nitrosamines assessments, and material compatibility studies, would be advantageous.

Key Responsibilities

1. Serve as SME for commercial GMP manufacture and testing of DS and DP at CDMOs, including review and approval of batch records, test records, investigations, and documentation for release.
2. Provide expert review, editing, and approval of documentation such as master production records, SOPs, validation protocols, and quality reports.
3. Support technical transfer of DS/DP processes within GMP and to future CDMOs, ensuring PPQ and validation status are maintained per industry standards.
4. Support drug product characterization and establish CQAs and markers predictive of clinical efficacy and safety.
5. Engage with stakeholders and industry organizations to incorporate trends into control strategies.
6. Analyze production data post-PPQ using statistical methods for CPV, monitor DS/DP manufacturing data, and lead modifications of control strategies as needed.
7. Ensure compliance with SOPs, participate in quality investigations, and resolve manufacturing quality events promptly.
8. Maintain validated status of products in accordance with industry and regulatory standards.
9. Manage product lifecycle activities, including post-approval commitments and market expansion support.
10. Lead and participate in process development and validation strategies supporting clinical and commercial programs.
11. Assess process change impacts and support implementation in line with SOPs and regulations.
12. Prepare and review technical documents for health authority submissions.
13. Travel as needed for on-site oversight during manufacturing activities at CDMOs.

Requirements

Required knowledge

• Experience in Cell and Gene Therapy, including lentiviral vectors, plasmids, cell banks, and hematopoietic stem cell biology.
• Experience with risk-based approaches like FMEA, quality management systems, change management, deviations, and quality events.
• Experience working with third-party laboratories and assay technology transfers.
• Knowledge of regulatory submissions, inspections, and interpretation of GMP and ICH guidelines.
• Understanding of QbD principles, product lifecycle, and process validation within biopharma.

Skills & Abilities

• Strong scientific and technical skills with awareness of industry developments.
• Decision-making skills for complex technical issues and effective communication.
• Excellent verbal, presentation, and written skills.
• Critical thinking and ability to operate in a fast-paced environment.

Education and Experience

• BSc. in Chemistry, Biochemistry, Molecular Biology, Cell Biology, Chemical Engineering, or related field.
• Higher education qualifications in relevant science or engineering disciplines.
• Extensive experience in process validation or process development in the biopharmaceutical industry.