Senior Scientist, MSAT

TN United Kingdom; London; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a dynamic Senior Scientist to join their Drug Substance and Drug Product Manufacturing Sciences team. This role involves supporting late-phase process development and ensuring compliance with GMP standards. The successful candidate will collaborate with cross-functional teams and external partners to maintain high-quality manufacturing processes. With a focus on Cell and Gene Therapy, this position offers the opportunity to engage in innovative projects that impact patient care globally. If you are passionate about advancing gene therapies and thrive in a fast-paced environment, this role is perfect for you.

Qualifications

• Experience in Cell and Gene Therapy, especially with viral vectors.
• Proven track record in quality management and regulatory submissions.

Responsibilities

• Manage product manufacturing processes in line with program plans.
• Compile and approve documentation such as master production records.
• Analyze production data and lead modifications as needed.

Skills

Cell and Gene Therapy

Quality Management Systems

Statistical Methods

GMP Compliance

Technical Transfer

Process Validation

Critical Thinking

Education

BSc in Chemistry

Higher Education in Relevant Sciences

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, including late-phase process development, validation (as required), and maintenance of all DS/DP manufacturing processes to ensure 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 manage all product manufacturing processes in line with program plans, company objectives, and health authority expectations. The individual will collaborate 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 teams. Relevant experience in Cell Gene Therapy products, especially viral vector and cell therapies, is essential.

The candidate should have a comprehensive understanding of GMP, statistical methods, and quality control, with excellent attention to detail, communication, presentation, and organizational skills. Troubleshooting skills and the ability to work independently and in teams are crucial. 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 GMP manufacturing and testing of DS and DP at CDMOs, including review and approval of batch records, test records, investigations, and documentation.
2. Compile, review, edit, and approve relevant documentation such as master production records, SOPs, validation protocols, and reports.
3. Support technical transfer of processes within GMP and to future CDMOs, ensuring PPQ and validation status are maintained per guidelines.
4. Assist in drug product characterization and establish CQAs and markers predicting efficacy and safety.
5. Engage with stakeholders and industry organizations to incorporate trends into control strategies.
6. Analyze production data post-PPQ for CPV, monitor manufacturing data, and lead modifications as needed.
7. Maintain high quality standards in compliance with SOPs, data integrity, and quality investigations.
8. Ensure validated status of products in line with industry and regulatory standards.
9. Manage product lifecycle, including post-approval commitments and market expansion support.
10. Lead and participate in process development and validation strategies supporting clinical to commercial phases.
11. Assess process change impacts and support implementation according to SOPs and regulations.
12. Author and review technical documents for health authority submissions.
13. Travel as needed for on-site oversight at CDMOs.

Requirements

Required knowledge

• Experience in Cell and Gene Therapy, including lentiviral vectors, plasmids, cell banks, or related biologics/vaccines.
• Experience with risk-based approaches like FMEA.
• Proven track record in Quality management systems, change management, deviations, and quality events.
• Experience working with third-party laboratories for assay transfers and testing.
• Experience in comparability studies and regulatory submissions.
• Familiarity with regulatory inspections (FDA, EMA).
• Knowledge of FDA/EU, GMP, and ICH regulations.
• Understanding of QbD principles and product lifecycle management.
• Experience in process development, validation, and technology transfer within biopharma, especially in vector, cell, and gene therapy.

Skills & Abilities

• Strong scientific and technical proficiency, with awareness of industry developments.
• Decision-making skills for complex technical issues and effective communication.
• Excellent verbal, presentation, and written communication 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 sciences or engineering.
• Extensive experience in biopharmaceutical process validation or development.