Senior Director, Analytical Development and Quality Control
Core
Define and execute analytical development and quality control strategies for biologics (protein therapeutics) from candidate selection through commercialization readiness in a lean, virtual model.
Role type
Senior Director, Analytical Development & Quality Control
Builds
Analytical strategies, GMP documentation, batch data, and regulatory submission content for protein therapeutics.
Domain
Biopharmaceuticals / Analytical Chemistry / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical strategy definition, method lifecycle management, GMP compliance, technical leadership, cross-functional partnership, budget management, inspection readiness, health authority response, technology transfer oversight, data integrity principles
Preferred skills
Experience with CDMOs and contract testing partners, emerging analytical technologies, diverse team building
Technologies
Chromatography, protein characterization techniques
Responsibilities
Define long-term analytical and QC operating models and governance; Lead analytical strategies for protein therapeutics across development phases; Establish phase-appropriate control strategies (method development, validation, specifications, stability); Serve as senior partner to CMC, Regulatory, and Supply Chain teams; Build and lead a high-performing analytical organization; Provide hands-on oversight of CDMOs and contract labs; Lead high-impact technical and GMP issue resolution; Drive inspection readiness and regulatory submission support; Manage departmental budgets and external spend.
Seniority
Senior Director, strategic leadership with hands-on technical execution
