Analytical Development Lead

About the role

You will act as the analytical subject matter expert across a diverse portfolio of development projects, guiding strategic decisions from method creation to regulatory submission. The role requires you to oversee analytical development work conducted by external CDMOs and ensure all deliverables meet stringent quality standards. You will review and interpret complex data, protocols, and reports to safeguard product integrity and project timelines. Collaboration with colleagues across Regulatory Affairs, Quality, and Supply Chain will be central as you represent analytical science in cross-functional discussions. You will support stability studies, specification setting, and degradation assessments to define robust product profiles. Additionally, you will contribute analytical expertise to regulatory submissions and health authority responses, ensuring scientific accuracy and compliance. Your work will directly enable the development of new medicines, clinical trials, and regulatory approvals, reinforcing our mission that every single patient matters.

Key facts

What you'll do

• Assume ownership of the analytical strategy as the primary subject matter expert for assigned development programs.
• Supervise analytical development activities performed by external contract development and manufacturing organizations to ensure timely and high-quality execution.
• Scrutinize and interpret analytical data, method validation reports, and protocol documents supplied by CDMOs.
• Drive stability study programs, define product specifications, and conduct degradation pathway assessments.
• Integrate analytical insights into regulatory documentation and respond to technical queries from health authorities.
• Classify analytical risks early in project lifecycles and devise mitigation plans to prevent downstream delays.
• Monitor regulatory updates, industry trends, and emerging technologies to maintain methodological relevance.
• Orchestrate end-to-end analytical workstreams, aligning project plans with timelines and budgets.
• Synchronize analytical activities across multiple external partners and laboratory environments.
• Verify that all analytical deliverables remain consistent with project objectives and development strategies.
• Resolve technical challenges proactively, applying scientific reasoning to overcome complex issues.
• Provide concise progress updates to project teams, stakeholders, and management on analytical status.
• Offer technical guidance and analytical thought leadership to cross-functional teams during decision-making.
• Act as a bridge between analytical development and program teams to support on-time product delivery.
• Contribute to internal continuous improvement initiatives, standardizing best practices across projects.
• Support the creation and maintenance of procedures, templates, and scientific standards for analytical workflows.

Requirements

• Hold a degree in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, or a closely related scientific discipline.
• Confidently demonstrate strong pharmaceutical analytical development experience across multiple projects.
• Possess knowledge of a diverse range of analytical characterization techniques and their appropriate application.
• Have experience reviewing and interpreting analytical data, method validation reports, and technical documentation.
• Show working knowledge of United States Pharmacopeia, International Council for Harmonisation guidelines, and regulatory requirements.
• Exhibit robust problem-solving capabilities and the ability to interpret complex scientific data accurately.
• Bring strong written and verbal communication skills to interact effectively with technical and non-technical audiences.
• Display meticulous attention to detail and accuracy when handling analytical data and regulatory documents.
• Demonstrate the capacity to manage multiple priorities in a fast-paced, deadline-driven environment.
• Show an understanding of quality management systems and regulatory submission processes.
• Commit to adhering to company policies, standard operating procedures, and regulatory compliance.
• Exhibit teamwork orientation and the ability to collaborate with global stakeholders across functions.
• Willingness to travel occasionally within the Cambridge office framework and to support project needs.
• Availability to work within the hybrid schedule, requiring a minimum of three days in the Cambridge office per week.

Practical notes

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Engagement: Full-time

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Location: Cambridge

• Hours: Full-time
• Travel: Occasional travel within the Cambridge office framework may be required to support project and partner needs.
• Visa: Sponsorship may be considered for suitable candidates depending on role and location requirements.
• Deadline: Please apply in line with company timelines as outlined in the application process.