Senior Scientist - Analytical Development

Orchard Therapeutics; London; Hybrid; GBP 40,000 - 80,000; Full time

Job summary

An innovative company at the forefront of gene therapy is seeking a talented analytical development professional. This role involves managing analytical projects, leading method development, and ensuring compliance with regulatory standards. You'll work in a dynamic environment, collaborating with internal teams and external partners to drive advancements in cell and gene therapies. If you're passionate about transforming lives through cutting-edge science and have a strong background in analytical techniques, this is your chance to make a meaningful impact in the biotech industry.

Qualifications

• 2+ years experience in managing analytical development projects.
• Understanding of FDA, EMA, GMP, WHO and ICH regulatory requirements.
• Experience in assay development and troubleshooting.

Responsibilities

• Manage analytical development plans for early-stage programs.
• Lead the development and qualification of analytical methods.
• Maintain accurate lab records and reports for assay development.

Skills

Analytical Method Development

Project Management

Problem Solving

Interpersonal Skills

Communication Skills

Education

BSc in Biotech-related Discipline

MSc in Biotech-related Discipline

PhD in Biotech-related Discipline

Tools

Flow Cytometry

PCR

Immunoassays

ddPCR

Protein Detection Techniques

Job description

Location: London, Hybrid

Reporting to: Director, Advanced Analytics

Job Summary

Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, curative cell and gene therapies. Orchard has its global headquarters in London and U.S. headquarters in Boston, and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.

As a key member of the Global Analytical Development Team, this role will be responsible for supporting analytical development for early phase programs and execution of method development at Orchard. This will include experiment design, acceptance criteria setting, experiment execution and data analysis of a range of analytical methods. This is an exciting opportunity for a well-qualified candidate to join an international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.

Key Responsibilities

• Manage the analytical development plan of an early-stage program in development as a key member of a CMC team.

• Single point of contact for projects executed at external parties such as CDMOs, CROs or vendors.

• Lead the development and qualification of analytical methods applicable for cell and gene therapy programs.

• Performing and developing analytical methods including protein and cell-based tools, LVV analytics, immunoassays and ddPCR.

• Assessment of novel equipment and methodologies.

• SOP-writing to support activities as required including tech transfer to internal departments or external partners.

• Maintenance and completion of accurate lab-based records and final reports to support internal analytical assay development activities as required.

• Other activities that may be assigned.

Experience & Knowledge

• At least 2-years experience of managing analytical development projects

• Comprehensive understanding of the needs of process development for both LVV and gene modified cell product

• Good understanding of FDA, EMA, GMP, WHO and ICH regulatory requirements and standards for analytical methods would be an advantage.

• Assay development experience with excellent problem solving and troubleshooting abilities.

• Proven ability to drive analytical method development using internal and external resources

• A proven understanding of analytical techniques such as flow cytometry, enzymatic activity assessment, immunoassays, and protein detection. An understanding of single cell sequencing and analysis, PCR, and primary cell culture differentiation cells is required.

• Performing and developing methods for autologous cell therapy and lentiviral vector assessment is desirable.

• Understanding of key components for tech transfer of analytical methods to GMP laboratories would be desirable.

Skills & Competencies

• Excellent interpersonal skills

• Understanding of pharmaceutical life cycle

• Outstanding organizational skills including project management

• Excellent written and oral communication skills

• Creative problem solver

• Ability to operate in a fast-paced, multi-disciplinary industrial environment

Education

• BSc/MSc in biotech-related discipline

• Ideally, a PhD in a biotech related discipline and 5-years post doc experience