Key Responsibilities
Laboratory Operations
- Lead and manage day-to-day analytical laboratory operations to ensure timely delivery of high-quality data.
- Oversee analytical method development, method validation/qualification, and method transfer for pilot-scale processes and products.
- Manage laboratory planning, resourcing, and budgets to meet project timelines and quality standards.
- Champion safe working practices and ensure operations meet environmental, health, and safety standards.
- Implement and maintain data integrity controls, SOPs, and quality documentation for all analytical activities.
Collaboration & Technology Transfer
- Collaborate with process, manufacturing, quality, and external partners to support technology transfers and scale-up activities.
- Establish and maintain productive relationships with internal stakeholders, CMOs, and contract laboratories.
Problem Solving & Quality
- Drive problem solving for analytical issues, propose pragmatic corrective actions, and support investigations.
- Ensure laboratory compliance with regulatory requirements, GMP principles, and data integrity standards.
- Foster continuous improvement initiatives within analytical operations.
Team Leadership & Development
- Coach, develop, and manage a multidisciplinary team of scientists and technicians.
- Foster an inclusive team environment that supports individual development, wellbeing, and professional growth.
- Influence cross-functional projects and guide teams to deliver high-quality analytical science.
Documentation & Reporting
- Prepare and review technical reports, protocol documents, and sections of regulatory submissions.
- Participate in data review, stability study design, and regulatory-compliant analytical reporting
