Manager / Sr Manager Scientist CMC analytical development
Core
Lead analytical development and quality control for therapeutic antibodies, managing outsourced QC testing, specifications, and regulatory submissions.
Role type
Senior IC scientist (CMC analytical development) with project leadership
Builds
Therapeutic antibody drug substances and drug products
Domain
Biotechnology / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development and validation, GMP and ICH regulations, statistics, project management, change control management, deviation and OOS investigation, reference standard management, stability program management, CMC module 3 review
Preferred skills
Experience with outsourced QC testing, process performance evaluation, technical discussions with commercial teams
Technologies
None explicitly stated
Responsibilities
Author internal specification documents for bulk drug substance and drug product; manage change controls, deviations, and OOS investigations at external vendors; manage critical reagents and reference standard inventories; maintain data repository of product quality via control charts; follow up on annual stability trending; manage analytical method life cycle and performance trending across sites; review CMC module 3 sections for global submissions
Seniority
Senior, hands-on IC with project leadership
