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PhD Research Scientist
4 months ago
Principal Scientist, Cell and Gene Technical Development
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. OTL) is looking for a Scientist I or II (depending on experience) for the Process Development team, focused on the development of analytical assays for Orchard Therapeutics' innovative gene-modified cell-based therapeutic products. Primary activities will include developing, validating and performing analytical assays for process development, QC and characterization of lentiviral vector and HSC gene therapy products. The post may also include research with internal departments and external partners, including development, validation and technology transfer, to support OTL's product pipeline programs. The role will be based in Orchard's London Hammersmith site where the state-of-the-art development laboratories are located.
Develop, validate and perform analytical assays for process development, implementation as QC and/or characterization assays for lentiviral vector and HSC gene therapy products
# Involvement in the transfer of processes and analytical methods from external collaborators and internal Orchard Research team to the Technical Development team.
# Participate in the Technical Development team through generation and testing of lentiviral vectors, and involvement in the optimization and improving lentiviral vector and HSC manufacturing processes.
# Assist in lab management duties, stock management and equipment maintenance and other practical day-to-day activities in the lab.
# Keep accurate and contemporaneous records of all development activities and analysis in Orchard's electronic lab notebook, presentations and/or reports, and present to the wider team/department.
# Authoring, reviewing and editing batch records, SOPs, development protocols and reports for internal and external analytical development, and CMC regulatory submissions.
# As required, manage activities at CDMOs and CTOs for the tech transfer, development, and validation of analytical methods, including the design, review and approval of associated protocols, test records/forms, reports and SOPs.
# Required Knowledge: As a Proven Technical Expert In The Development, Manufacture And Delivery Of Cell-based Therapy Products With Significant Applied Experience In The Biotechnology Industry, This Candidate Will Possess Experience in the biotechnology or pharma industry (including PhD or industry/academic work where relevant), with the ability to design, validate and apply analytical methods for cell and gene therapy product development, characterization and QC testing. Hands-on experience of the development, validation and application of analytical techniques such as FACS, ddPCR, ELISA, DNA sequencing, qPCR/PCR, cell culture and cell-based assays. Knowledge of European and US Pharmacopeia methods and FDA, EMA, GMP, WHO and ICH regulatory requirements if preferred. Excellent written and oral communication skills, excellent interpersonal skills, outstanding organizational skills, creative problem solver, ability to operate in a fast-paced, multi-disciplinary industrial environment, proven ability to work effectively in multi-site, cross-functional working environment.
BSc/MSc with relevant industry experience, or PhD in biotechnology/biological sciences, gene therapy, analytical development or an associated discipline.
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