Senior Scientist, Cell & Gene Therapy Technologies

Orchard Therapeutics, Ltd. (OTL) is looking for an experienced Senior Scientist to develop and optimize lentiviral vector (LVVs) platform(s). This is a great opportunity to join the growing Process Development team within Cell & Gene Therapy Technologies department and contribute to the delivery of Orchard Therapeutics innovative gene-modified cell-based therapeutic products. The job role will include molecular biology, cell line development, process development, process characterization and manufacture of lentiviral vectors. The post-holder will also input into the transfer and implementation of optimized processes to GMP to support OTL's product pipeline programs.

Key Elements and Responsibilities

• Develop stable cell lines for LVVs;
• Design, develop and improve process(es) (USP and DSP) for LVVs to deliver robust manufacturing platforms for early and late-stage clinical and commercial development;
• Develop and perform cell-based and biochemical assays to characterise LVV processes and products;
• Execute experimental plans, analyse and interpret experimental data, maintain experimental results in relevant databases and write technical reports;
• Provide hands-on technical expertise/scientific guidance to team members and supervision of junior colleagues;
• Contribute to the routine lab maintenance;

• Contribute to the transfer of stable cell lines and improved processes to GMP and assist with oversight of manufacturing activities as required;
• Prepare, review and complete protocols/SOPs, study reports and assist with regulatory submissions;
• Communicate, share and discuss work progress internally and externally;
• Other responsibilities may be assigned.

Requirements

Required knowledge

• In-depth knowledge on the state-of-the-art of cell & gene therapy products and available technology, more specifically regarding viral vectors;
• PhD+3 years (academic/industrial) or additional industrial experience with development, manufacture and delivery of viral vectors, preferably retro and lentiviral vectors;
• Demonstrated skills and hands-on experience in tissue culture techniques and handling of adherent and suspension cell lines in different culture systems;
• Demonstrated skills and hands-on experience in molecular biology and vectorology, including cloning, standard DNA and RNA technology, analyses with qPCR, recombinant protein expression and assessments with SDS-PAGE, Western blot, ELISA, flow cytometry and others;
• Demonstrated knowledge and hands-on experience with stable cell lines development for retro and lentiviral vectors;
• Demonstrated knowledge in designing and developing processes for LVV production and purification;
• Experience in developing and performing analytical methods for stable cell lines and LVV characterization;
• Use of more specialist lab equipment e.g. flow cytometers, cell counters, cell sorters, microscopes and imaging systems, bioreactors, AKTA, TFF systems, controlled-rate freezers etc;
• Proficient with MS office, Prism, SnapGene, FlowJo, e-lab books and other commonly used software;
• Experience with DoE software (s) and statistical analyses is a plus;
• Understanding of and familiarity with regulatory guidance governing stable cell lines and vector-based products is a plus;

Skills & Abilities

• Ability to work collaboratively as part of a multi-disciplinary team, or independently as necessary;
• to prioritise work and meet deadlines;
• Independently design and execute experiments following laboratory procedures, appropriately analyse data and provide an interpretation of results;
• and written skills for report writing, team communications and presentations;
• Creativeness, motivation, and troubleshooting skills to solve problems and/or develop new technical capabilities;
• Ability to operate in a fast paced, multidisciplinary industrial environment

Education

• A minimum PhD or equivalent in biotechnology, process development, cell line development, cell and gene therapy, biological sciences, or other relevant scientific discipline.