Senior Scientist - Analytical Development and Transfer
Core
Providing scientific leadership for analytical technology transfers across the CMC portfolio to ensure successful delivery of site readiness activities and compliant analytical methods.
Role type
Senior Scientist - Analytical Development and Transfer
Builds
Robust, sustainable, and inspection-ready analytical control strategies for internal laboratories, manufacturing sites, and external partners.
Domain
Pharmaceutical manufacturing (CMC) / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP and GxP compliance, analytical method transfer and co-validation, risk-based validation (ICH), HPLC and related methodologies, regulatory submission support, stakeholder management, technical documentation, continuous improvement, mentoring
Preferred skills
Leading end-to-end method transfers across sites and CMOs, establishing governance models, driving cross-organizational initiatives
Technologies
HPLC, ICH guidance frameworks
Responsibilities
Develop and execute analytical technology transfer strategies, lead complex transfer programs, establish and govern transfer documentation, manage vendor and contract laboratory relationships, serve as technical authority for investigations and deviations, partner with cross-functional teams, contribute to departmental strategy, identify improvement opportunities, mentor scientific staff
Seniority
Senior, hands-on IC with potential for direct reports
