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