OBJECTIVES:
The Manager, Analytical Development is responsible for leading and executing analytical method development, qualification, validation, and assay transfer activities to support biologics and vaccine development programs from early development through Phase 2 clinical trials. The position holder applies strong scientific judgement in the design and execution of analytical methods and is well-versed in current biologics analytical development trends across a broad range of modalities, including viral, mRNA, and protein-based vaccines.
The position holder manages a team of analytical scientists and provides hands-on scientific leadership and project ownership. The role works in close collaboration with Early Development and Preclinical, Process Development, Quality Control, Regulatory Affairs, and external partners to ensure analytical readiness, non-GMP testing support, compliance with regulatory expectations, and timely program progression.
RESPONSIBILITIES:
Analytical Development
- Lead and oversee the Analytical Development (AD) team in the execution of analytical method development, optimisation, qualification, and validation for in-process controls, release testing, and product characterisation.
- Apply sound scientific judgement to method selection, troubleshooting, lifecycle management, and continuous improvement.
- Analyse and interpret experimental data using appropriate statistical and scientific approaches, including assay variability analysis.
Assay Transfer & External Collaboration
- Lead and support assay transfer activities to internal QC laboratories and external partners (e.g. CMOs, CROs, CTOs).
- Prepare, review, and execute assay transfer protocols, reports, comparability assessments, and acceptance criteria.
- Serve as the analytical point of contact during assay transfer, ensuring successful method implementation and effective troubleshooting.
- Interface with external testing partners to ensure timely, compliant, and robust assay transfer execution.
Regulatory & Documentation
- Author and review high-quality technical documents, including protocols, reports, technical memoranda, and regulatory sections supporting IND/IMPD submissions.
- Support regulatory submissions and interactions by providing analytical rationales, assay validation data, and responses to regulatory questions.
- Ensure accurate, complete, and compliant documentation in laboratory notebooks and data records.
Project & Matrix Collaboration
- Oversee and coordinate non-GMP, fit-for-purpose testing to support Early Development and Preclinical, Process Development, and Tech Transfer activities.
- Manage analytical development deliverables for assigned projects in alignment with overall CMC and project strategies.
- Partner cross-functionally with Process Development, Drug Product Development, Quality Assurance, Regulatory Affairs, and Project Management to advance development programs.
- Contribute to development strategies and planning by identifying analytical risks, mitigation actions, and resource needs.
People & Laboratory Leadership
- Manage Analytical Development staff, including recruitment, definition of individual and team objectives, and performance management.
- Plan and manage FTE capacity aligned with anticipated Analytical Development, assay transfer and non-GMP testing workloads.
- Optimise resources utilisation (human, equipment, consumables etc) for the Analytical Development function, closely aligned with company needs and priorities.
- Coach, mentor, and develop team members to build technical capability and support succession planning.
- Coordinate projects within the Analytical Development (AD) group and allocate resources based on project lifecycle, resource requirements, and agreed priorities.
- Support safe, compliant, and efficient laboratory operations, including equipment upkeep and continuous improvement initiatives.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- PhD (or Master's) in Life Sciences or a related discipline with a minimum of 6 (8) years of relevant experience.
- Demonstrated scientific expertise in molecular biology and microbiological or cell-based analytical methods experience in physicochemical analytical methods is a plus.
- Minimum of 2 years of direct people management experience preferred.
- Willingness and ability to work hands-on in the laboratory, as required, to drive method development, troubleshooting, and assay transfer activities.
- Working knowledge of GMP environments and regulatory expectations for analytical methods and assay validation, with a minimum of 4 years in the pharmaceutical industry preferred.
- Prior assay transfer experience (development to QC and/or external partners) preferred.
- Strong scientific writing, data interpretation, and verbal communication skills.
- Proven ability to work effectively in a matrix, multidisciplinary, and international environment.
- Highly motivated, collaborative, detail-oriented, and able to manage multiple priorities effectively.
