Scientist - Analytical Development

Orchard Therapeutics - U.S.; London; On-site; GBP 40,000 - 60,000; Full time

Job summary

A global therapeutics company located in London is seeking a highly qualified individual to support analytical testing related to process development activities. This lab-based role involves the development and qualification of methods for cell and gene therapies, working within a dynamic and multidisciplinary team. Ideal candidates should possess a PhD or equivalent experience in a biotech-related discipline and demonstrated skills in assay development and analytical techniques.

Qualifications

• Experience in executing flow cytometry experiments.
• Understanding of single cell sequencing and analysis.
• Knowledge of FDA, EMA, GMP, WHO, and ICH standards.

Responsibilities

• Develop and qualify analytical methods for gene therapy.
• Maintain accurate lab records and final reports.
• Perform data reviews and SOP writing as needed.

Skills

Assay development experience

Excellent problem solving

Flow cytometry

Creative problem solver

Excellent organizational skills

Education

PhD or equivalent in Biotech-related discipline

Job description

Location

London, UK

Reporting to

Director, Advanced Analytics

Job Summary

As a key member of the Global Analytical Development Team, this lab-based role will be responsible for supporting analytical testing related to process development activities 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 Elements And Responsibilities

• Development and qualification of analytical methods applicable for cell and gene therapy programs.
• Maintenance and completion of accurate lab-based records and final reports to support internal analytical assay development activities as required.
• Performing and developing analytical methods including protein and cell-based tools, immunoassays and ddPCR.
• Assessment of novel equipment and methodologies.
• Tissue culture of primary cells, cell lines, as well as cell bank generation and appropriate record maintenance.
• SOP-writing to support activities as required including tech transfer to internal departments or external partners.
• Presentation of method development plans and results to the wider department and functional teams as requested.
• Support development and qualification of analytical methods at CMOs and CTOs as required. This may include performing data, final report and SOP reviews.
• Other activities as may be assigned.

Requirements

Required Knowledge

The Successful Candidate Will Either Possess a PhD Or Equivalent Level Of Experience In Industry Following BSc/MSc In Biotech-related Discipline And The Following

• Assay development experience with excellent problem solving and troubleshooting abilities.
• 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 would be advantageous.
• Experience in executing flow cytometry experiments and/or single cell-based assays.
• Performing and developing methods for autologous cell therapy and lentiviral vector assessment is desirable.
• Knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements and standards for analytical methods would be an advantage.
• Understanding of key components for tech transfer of analytical methods to GMP laboratories would be desirable.

Skills And Abilities

• Excellent interpersonal skills
• Outstanding organizational skills
• Excellent written and oral communication skills
• Creative problem solver

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