At a Glance
- Tasks: Drive gene therapy manufacturing processes and support regulatory submissions.
- Company: Join Orchard Therapeutics, a leader in innovative gene therapies.
- Benefits: Competitive salary, career growth, and a chance to make a real impact.
- Other info: Collaborative environment with opportunities for professional development.
- Why this job: Be at the forefront of transforming lives through cutting-edge gene therapy.
- Qualifications: PhD with 4+ years in biotech, focusing on cell and gene therapy.
The predicted salary is between 43200 - 72000 £ per year.
Location: London, UK
Reporting to: Senior Scientist, Global Technical Development
Job Summary
Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the life of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cell (HSC). Orchard has its global headquarters in London and U.S. headquarters in Boston.
Technical Development sits within Technical Operations at Orchard and is responsible for the development and characterization of Lentiviral Vectors (LVVs) and Drug Substance/Drug Product production processes, which meet patient demand for therapeutic products of the best quality.
The Senior Scientist, Global Technical Development will be primarily responsible to drive and support project activities for development of ex-vivo gene therapy manufacturing processes along the development pathway to the point of process qualification. The creation of high-quality source documents and expert review of regulatory documents to support IND/CTA and BLA/MAA filings is a key component of this role. They would be heavily involved with both the Process Development Team and CMC Program team, working on cell process development and collaborating with other functions to drive key project goals.
Key Elements And Responsibilities
- Design manufacturing processes and characterize gene modified HSC processes and products to deliver robust platforms for early and late-stage clinical development.
- Design complex experiments, perform data analysis and author reports suitable for regulatory submissions using senior-level judgement and expertise.
- Provide expert compilation of documents. This includes risk assessments, development protocols and reports, batch records, standard operating procedures and investigations.
- Preparation CMC regulatory submissions (e.g. INDs, BLAs, Scientific advice) and source documents.
- Provide strategic input into development plans, program CMC strategies and departmental/functional activities, and deliver on agreed actions.
- Present development strategy plans and results to the wider department and functional teams, and discuss conclusions and next steps.
- Co-ordinate development activities with preclinical, QA and other departments to ensure the achievement of company timelines and milestones.
- Lead oversight of development at company designated Contract Development and Manufacturing Organizations (CDMOs).
- Collaboratively participate in multi-disciplinary teams to perform risk-based analysis of processes where appropriate and providing impact assessments as required.
- Identify and implement validation requirements pre PPQ, in accordance with current industry and CMC regulatory standards and best practices in cell and gene therapy.
- Other activities may be assigned.
Requirements
As a Proven Technical Scientific Expert In The Development, Manufacture And Delivery Of Cell-based Therapy Products With Significant Applied Experience In The Biotechnology Industry, This Candidate Will Possess
Required Knowledge & Experience
- Substantial experience in the biotechnology or pharma industry e.g. PhD+ >4 years' experience (depending on scope and relevance), with a primary focus on the development, manufacture, and delivery of cell and gene therapy products.
- In-depth technical experience with a proven track record of developing, integrating and implementing equipment and processes for clinical and/or commercial application.
- Understanding of Tech.
Senior Scientist (12 month fixed term), Global Technical Development in London employer: Orchard Therapeutics - U.S.
Orchard Therapeutics, a Kyowa Kirin company, is an exceptional employer located in the heart of London, offering a dynamic work culture that fosters innovation and collaboration in the field of gene therapy. Employees benefit from a supportive environment that prioritises professional growth through continuous learning opportunities and involvement in groundbreaking projects aimed at transforming patient lives. With a commitment to excellence and a focus on employee well-being, Orchard Therapeutics stands out as a rewarding place to advance your career in biotechnology.
Contact Details:
Orchard Therapeutics - U.S. Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Senior Scientist (12 month fixed term), Global Technical Development in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and pharma industry. Attend events, webinars, or even casual meet-ups. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by practising common questions specific to gene therapy and biotechnology. We recommend doing mock interviews with friends or mentors to boost your confidence and refine your answers.
✨Tip Number 3
Showcase your expertise! Bring along examples of your previous work, like reports or presentations, to demonstrate your skills during interviews. This will help you stand out as a candidate who knows their stuff.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are genuinely interested in joining our team at Orchard Therapeutics.
We think you need these skills to ace Senior Scientist (12 month fixed term), Global Technical Development in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Scientist role. Highlight your relevant experience in gene therapy and any specific projects that align with what we do at Orchard Therapeutics. We want to see how your background fits into our mission!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about gene therapy and how your skills can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Technical Skills:In your application, don’t forget to showcase your technical expertise, especially in developing and characterising manufacturing processes. We’re looking for someone who can hit the ground running, so let us know what you bring to the table!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you get all the updates directly from us. Plus, it’s super easy!
How to prepare for a job interview at Orchard Therapeutics - U.S.
✨Know Your Science
Make sure you brush up on the latest advancements in gene therapy and cell-based products. Be prepared to discuss your previous experiences in detail, especially any complex experiments you've designed or led. This will show that you’re not just knowledgeable but also passionate about the field.
✨Prepare for Technical Questions
Expect to face some tough technical questions related to Lentiviral Vectors and CMC regulatory submissions. Review your past projects and be ready to explain your thought process and decision-making. Practising with a friend or colleague can help you articulate your expertise more clearly.
✨Showcase Your Collaboration Skills
This role involves working closely with various teams, so be ready to share examples of how you've successfully collaborated in the past. Highlight any multi-disciplinary projects you've been part of and how you contributed to achieving common goals. This will demonstrate your ability to work well in a team environment.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company’s future projects or challenges they face in gene therapy development. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
