Scientist - Cell Process Development: Fixed Term 12 months
Location: London, UK
Reporting to: Senior Scientist, Cell Process Development
Job Summary: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. The position is available for a 12 month period.
Orchard Therapeutics, Ltd. (OTL) is looking for a Scientist for the Cell Process Development team to manage activities related to the development, manufacture and delivery of Orchard Therapeutics innovative gene-modified cell-based therapeutic products. Primary activities will include the process development and optimisation of our drug product manufacturing process, investigating all manufacturing process steps including cell selection, transduction, culture, and formulation. Research will be conducted both internally and with external partners, from pre-clinical research through to commercialization. The post may also include tech-transfer, validation and GMP execution of manufacturing processes and controls to support OTL’s product pipeline programs. The role will be based in based in Orchard’s London Hammersmith site where the development laboratories are located.
Key Elements and Responsibilities
- Involvement in the transfer of cell processes and controls from academic and external collaborators to the cell processing team.
- Design and implement improvements in processes and characterize HSC-based gene modified cell processes to deliver robust platform processes suitable for early and late-stage clinical and commercial development.
- Develop and perform analytical assays to support process development
- Generate lentiviral vectors for transduction optimisation experiments
- Assessment of novel equipment and methodologies.
- Involvement in compilation, review, editing and approval of batch records, standard operating procedures, development protocols and reports.
- Design, perform and support experiments and data analysis, and prepare data presentations and reports required and suitable for regulatory submissions.
- Presentation of development plans and results to the wider department and functional teams as requested.
- Participate in development activities with the research, pre-clinical development, QA, QC, clinical development and commercial departments to ensure the successful achievement of company timelines and milestones.
- Assist in lab management duties, stock management and equipment maintenance.
- . As required, assist with oversight of manufacturing at company designated Contract Manufacturing Organizations (CMOs).
- Other activities as may be assigned.
As a proven technical expert in the development, manufacture and delivery of cell-based therapy products with ideally with applied experience in the biotechnology industry, this candidate will possess:
- PhD or equivalent level of industry experience following BSc/MSc in biotechnology/biological sciences, with a primary focus on the development, manufacture, distribution and delivery of cell and gene-based therapy products.
- Technical experience with a proven track record of developing, integrating and implementing equipment and processes for clinical and/or commercial application:
- o Cell isolation/purification
- o Cell culture o Cell transduction o Cell washing/volume reduction o Formulation and final fill of cell-based products o Related analytical methods
- Expertise of gene therapy vectors and autologous gene modified cellular therapies, and associated analytical methods
- DOE and QBD experience a plus
- Experience or understanding of regulatory filings and associated reports/sections writing and knowledge of FDA, EMA, GMP and ICH regulatory requirements a plus
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
Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.
We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.
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