Senior Director, Analytical Development and Quality Control

Responsibilities

• Define long-term analytical development and quality control strategy and operating models for biologics portfolios
• Lead development and execution of analytical strategies from candidate selection through commercialization
• Establish phase-appropriate analytical control strategies, including method validation, specifications, and stability programs
• Manage and develop a senior team of leaders in Analytical Development and Quality Control
• Provide strategic oversight of CDMOs and contract testing laboratories to ensure timely delivery of GMP testing
• Serve as the primary analytical and QC representative on cross-functional CMC teams
• Lead high-impact technical and GMP issue resolution, including investigations, deviations, OOS/OOT events, and CAPAs
• Contribute to regulatory submissions (IND, BLA, IMPD) and support health authority interactions
• Manage departmental budgets, resource planning, and external spend

Requirements

• Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Molecular Biology, Chemical Engineering, or related field with 15+ years of industry experience
• Alternatively, an M.S. with significant additional relevant industry experience
• Deep expertise in analytical development and QC for biologics (mAbs, recombinant proteins, fusion proteins)
• Extensive experience with analytical method development, qualification, transfer, and validation
• Proven leadership experience building and mentoring high-performing analytical organizations
• Significant experience managing CDMOs and external partners in an outsourced model
• Strong understanding of GMP requirements, data integrity, and quality systems
• Track record of authoring and defending analytical content for regulatory submissions

About the Company

Generate:Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development. By integrating machine learning with large-scale experimentation, the company aims to design proteins with defined biological intent to reduce the uncertainty, time, and cost of developing protein-based medicines.