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- Tasks: Lead the Analytical Sciences team in developing and validating analytical methods for Cell and Gene Therapy.
- Company: Join a pioneering organization focused on transformative therapies in a fast-paced, innovative environment.
- Benefits: Enjoy a hybrid work model with opportunities for professional growth and collaboration.
- Why this job: Make a significant impact on life-saving therapies while fostering a culture of scientific excellence.
- Qualifications: PhD or MSc in a relevant field with extensive experience in analytical methods and regulatory compliance.
- Other info: Be part of a dynamic team that values innovation and continuous improvement.
The predicted salary is between 72000 - 108000 £ per year.
Location: London (Hybrid)
Reports to: Senior Director, Manufacturing & Analytical Sciences and Technology (MSAT)
Position Summary
We are seeking a dynamic and experienced leader to join our MSAT (Manufacturing Science and Technology) team as Director of Analytical Sciences and Technology. This individual will lead the late-phase Analytical Sciences team, overseeing the qualification, validation, and deployment of analytical methods while ensuring effective control strategies and ongoing method improvements. The role will be integral to the lifecycle management of Cell and Gene Therapy products, particularly focusing on viral vectors and cell therapies.
The Director will play a key role in developing and executing phase-appropriate strategies for test methods, partnering with internal and external stakeholders, and representing the organization during regulatory inspections.
This role provides an exciting opportunity to influence the advancement of transformative Cell and Gene Therapy products and develop a high-performing team in a fast-paced, innovative environment.
Key Responsibilities
Team Leadership:
• Lead the Analytical Sciences team within the MSAT organization to develop, qualify, validate, and manage robust analytical methods.
• Cultivate a culture of scientific excellence, collaboration, and continuous improvement.
Method Development and Compliance:
• Ensure compliance with ICH guidelines, FDA/EMA, and global regulatory expectations for analytical methods.
• Oversee drug product characterization and establish critical quality attributes (CQAs) to support clinical efficacy and safety.
Strategic Oversight:
• Develop science-based, risk-informed analytical validation strategies for pivotal to commercial phases.
• Chair the Orchard Specifications Committee, ensuring alignment with program goals and regulatory requirements.
Stakeholder Engagement:
• Collaborate with cross-functional teams and external partners, including CDMOs and contract labs, to drive method improvements and control strategy optimization.
• Actively engage with industry organizations to stay ahead of regulatory trends and incorporate them into control strategies.
Regulatory Support:
• Serve as a subject matter expert during inspections and author high-quality CMC documentation for regulatory submissions and amendments.
• Ensure inspection readiness and actively support health authority interactions.
Technology and Process Development:
• Develop and execute an Analytical Sciences technology roadmap aligned with manufacturing strategy.
Performance Management:
• Oversee the performance, development, and growth of the Analytical, MSAT team.
Required Knowledge & Experience
• Extensive experience in qualification, validation, trending, and continuous improvement of analytical methods.
• Proven ability to deliver high-quality documentation for regulatory submissions, including FDA/EMA inspections.
• Direct experience of working for a company in the fieldCell and Gene Therapy, particularly lentiviral vectors, plasmids, cell banks, or related biologics and vaccine characterization.
• Strong understanding of FDA, EMA, and ICH regulatory guidelines.
• Demonstrated success in managing third-party laboratories for assay development and validation.
Skills & Competencies
• Strong technical expertise with a history of scientific innovation and problem-solving.
• Exceptional communication skills, capable of effectively presenting complex technical issues to diverse audiences.
• Ability to prioritize and manage multiple projects under tight deadlines.
• Proactive leadership style, fostering trust, collaboration, and team performance.
• Skilled at building partnerships with internal teams and external stakeholders.
Education & Qualifications
• PhD or MSc in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Molecular Biology, Cell Biology, or Chemical Engineering).
• Significant experience in life sciences, preferably in MSAT roles focusing on analytical methods.
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Director, Analytical Sciences and Technology, MSAT employer: Orchard Therapeutics
Contact Detail:
Orchard Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, Analytical Sciences and Technology, MSAT
✨Tip Number 1
Make sure to highlight your leadership experience in analytical sciences. This role requires a dynamic leader, so be prepared to discuss how you've successfully led teams and fostered a culture of scientific excellence.
✨Tip Number 2
Familiarize yourself with the latest ICH guidelines and FDA/EMA regulations. Being well-versed in these will not only help you in the interview but also demonstrate your commitment to compliance and quality in analytical methods.
✨Tip Number 3
Prepare examples of your experience with method development and validation, especially in the context of Cell and Gene Therapy. Showcasing your direct experience with viral vectors or related biologics will set you apart from other candidates.
✨Tip Number 4
Network with professionals in the field of MSAT and analytical sciences. Engaging with industry organizations can provide insights into current trends and challenges, which you can leverage during discussions with our team.
We think you need these skills to ace Director, Analytical Sciences and Technology, MSAT
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description and understand the key responsibilities and required skills. Tailor your application to highlight your relevant experience in analytical methods and leadership within the MSAT field.
Highlight Relevant Experience: In your CV and cover letter, emphasize your extensive experience with qualification, validation, and continuous improvement of analytical methods, particularly in the context of Cell and Gene Therapy. Provide specific examples of your achievements in these areas.
Showcase Leadership Skills: Demonstrate your leadership capabilities by discussing your experience in managing teams and fostering a culture of scientific excellence and collaboration. Mention any successful projects where you led cross-functional teams or engaged with external partners.
Prepare for Regulatory Focus: Since the role involves regulatory support, make sure to mention your familiarity with FDA, EMA, and ICH guidelines. Include any experience you have with regulatory submissions and inspections, as this will be crucial for the hiring team.
How to prepare for a job interview at Orchard Therapeutics
✨Showcase Your Leadership Experience
As a Director, you'll need to demonstrate your ability to lead teams effectively. Prepare examples of how you've cultivated a culture of scientific excellence and collaboration in previous roles.
✨Highlight Regulatory Knowledge
Be ready to discuss your experience with FDA, EMA, and ICH guidelines. Provide specific instances where you ensured compliance during method development or regulatory submissions.
✨Discuss Method Development Strategies
Prepare to talk about your approach to developing and validating analytical methods. Share insights on how you've implemented risk-informed strategies in past projects.
✨Emphasize Stakeholder Engagement
Illustrate your experience in collaborating with cross-functional teams and external partners. Highlight any successful partnerships that led to method improvements or optimized control strategies.
