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- Tasks: Lead the development of innovative processes for viral vector production.
- Company: Join Orchard Therapeutics, a global leader in gene therapy based in London.
- Benefits: Enjoy a dynamic work environment with opportunities for personal and professional growth.
- Why this job: Be part of a mission to transform lives through cutting-edge gene therapies.
- Qualifications: PhD or equivalent in relevant scientific fields; 5+ years in viral vector development required.
- Other info: Work in a diverse team and engage with various functional groups.
The predicted salary is between 54000 - 84000 £ per year.
Location: London (Hammersmith)
Reporting to:Director, Viral Vector Development
Technical Development sits within Technical Operations at Orchard and is responsible for the development and characterization of Lentiviral Vectors (LVVs) and DS/DP production processes, which meet patient demand for therapeutic products of the best quality.
Reporting to the Director, Viral Vector Development, the Principal Scientist, Viral Vector Development, will be responsible for the development of innovative, high-yield processes for production of LVVs for the defined project(s). The candidate will closely interact with other functional groups including analytics, cell process development, CMC and regulatory teams. This role is based in our Hammersmith, London facilities within our global headquarters and will suit candidates who would like to join a global company with a diverse and dynamic work environment that provides opportunities for sustained personal and professional growth.
Key Elements and Responsibilities
- Design, develop and improve upstream and downstream processes for LVVs to deliver robust manufacturing platforms for early and late-stage clinical and commercial development
- Execute experimental plans, analyse experimental data and write technical reports
- Provide hands-on technical expertise/scientific guidance to team members and supervision of junior colleagues
- Contribute to the transfer of improved processes to GMP and assist with oversight of manufacturing activities as required
- Assist in the reporting, investigation and resolution of deviations encountered during GMP production activities
- Prepare, review and complete protocols/SOPs, study reports and assist with regulatory submissions
- Communicate, share and discuss work progress internally and externally
- Perform landscape scouting to drive continuous improvement in quality, yield and COGs
- Provide expert review and approval of executed batch, records, test records and associated documentation for release of LVVs and plasmids used in their production.
Experience & Knowledge
- In-depth knowledge of state-of-the-art cell & gene therapy products and available technologies, more specifically regarding viral vectors
- Minimum of 5 years of experience with development, manufacture and delivery of viral vectors, preferably retro and lentiviral vectors including late phase product development
- Experience with risk-based approaches, such as Failure Modes and Effects Analysis
- Demonstrated skills and experience in adherent and suspension cell lines in different culture systems
- Demonstrated knowledge in designing and developing processes for LVV production and purification
- Experience in process characterization and validation of the large-scale cGMP production of lentiviral vectors
- Experience with specialised lab equipment e.g. bioreactors, AKTA, TFF systems, etc
- Proficiency with MS office, MFCS, SnapGene, Unicorn, e-lab books and other commonly used software is required. Experience with DoE software (s) and statistical analysis would be ideal.
- Knowledge of FDA, EMA, GMP and ICH regulatory requirements
- Knowledge of Quality Systems and QBD as they relate to GMP production operations, process optimization and process validation.
- Knowledge of statistical data analysis
- Knowledge of plasmid DNA manufacturing would be an asset.
Skills and Abilities
- Demonstrated skills and capability in planning, preparing, executing and reporting of process development and validation activities.
- Ability to operate in a fast paced, multidisciplinary industrial environment
- Creativeness, motivation, and troubleshooting skills to solve problems and/or develop new technical capabilities
- Excellent interpersonal and communication skills
- Ability to visualize / present data in order to communicate ideas, concepts and results to technical and non-technical audiences.
- Ability to independently design and appropriately analyse data and provide an interpretation of results
- Strong organization and planning skills to prioritise work and meet deadlines
Education
PhD, BSc or equivalent in biotechnology, process development, cell and gene therapy, biological sciences, or other relevant scientific disc
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Contact Detail:
Orchard Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Scientist, Viral Vector Development
✨Tip Number 1
Network with professionals in the gene therapy and viral vector development fields. Attend industry conferences, webinars, or local meetups to connect with potential colleagues and learn about the latest trends and technologies.
✨Tip Number 2
Familiarise yourself with the specific technologies and methodologies mentioned in the job description, such as lentiviral vectors and GMP production processes. This will not only boost your confidence but also demonstrate your commitment to the role during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences in process development and validation activities. Be ready to share specific examples of how you've tackled challenges in a fast-paced environment, as this will highlight your problem-solving skills.
✨Tip Number 4
Research Orchard Therapeutics and their recent projects or advancements in gene therapy. Understanding their mission and values will help you tailor your conversations and show that you're genuinely interested in contributing to their goals.
We think you need these skills to ace Principal Scientist, Viral Vector Development
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in viral vector development and gene therapy. Emphasise your technical skills, particularly in process development and validation, as well as any hands-on experience with bioreactors and other specialised lab equipment.
Craft a Compelling Cover Letter: In your cover letter, express your passion for gene therapy and how your background aligns with the role. Mention specific projects or experiences that demonstrate your ability to design and improve processes for LVV production.
Highlight Relevant Skills: Clearly outline your knowledge of regulatory requirements (FDA, EMA, GMP) and quality systems. Discuss your experience with statistical analysis and DoE software, as these are crucial for the role.
Showcase Communication Abilities: Since the role involves collaboration with various teams, highlight your interpersonal and communication skills. Provide examples of how you've effectively communicated complex scientific concepts to both technical and non-technical audiences.
How to prepare for a job interview at Orchard Therapeutics
✨Showcase Your Technical Expertise
Be prepared to discuss your in-depth knowledge of viral vectors and gene therapy products. Highlight specific projects where you've developed or improved processes for LVV production, and be ready to explain the methodologies you used.
✨Demonstrate Problem-Solving Skills
Expect questions that assess your troubleshooting abilities. Share examples of challenges you've faced in previous roles, particularly in GMP production, and how you resolved them using a risk-based approach.
✨Communicate Effectively
Since this role involves collaboration with various teams, practice articulating complex scientific concepts in a way that is understandable to both technical and non-technical audiences. Prepare to discuss how you've successfully communicated project progress in the past.
✨Prepare for Regulatory Discussions
Familiarise yourself with FDA, EMA, and ICH regulatory requirements as they pertain to gene therapy. Be ready to discuss how you've ensured compliance in your previous work, especially regarding process validation and quality systems.
