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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