Director, Analytical Science and Technology

@ Civica Rx

About Civica

Civica Rx is addressing critical shortages of essential generic injectable drugs in U.S. healthcare. Formed in 2018, Civica is a market-based nonprofit solution created by health systems and philanthropies. With nearly 60 health systems on board, it supports over 1,400 hospitals and supplies essential medicines to agencies including the U.S. Department of Veteran’s Affairs, Department of Defense, and the Strategic National Stockpile. Civica also extends its mission to consumers directly through CivicaScript.

A state-of-the-art 140,000 square foot manufacturing facility in Virginia soon will produce over three dozen sterile injectables and affordable biosimilar insulins.

Position Summary

The Director, Analytical Science and Technology is accountable for end-to-end biologics analytical method development, qualification, and performance in both development and QC labs. This role encompasses release methods, functional binding and cell-based activity assays, along with advanced characterization assays to demonstrate biosimilar comparability. The director will manage contract development labs, set analytical control strategies approved by the FDA, and support cGMP and regulatory requirements for BLA submissions.

Essential Duties And Responsibilities

• Oversee method transfer, optimization, and validation design following USP and ICH guidelines.
• Develop and own control strategies with development partners.
• Lead development and troubleshooting of advanced binding and cell-based assays.
• Support Regulatory Affairs in documentation for BLA submissions.
• Review protocols, validation, and stability data, and support USP and Compendial testing.
• Manage relationships with contract development organizations and supervise related work.

Minimum Qualifications

A BS/BA in chemistry, biochemistry, molecular biology, microbiology, biochemical engineering or related field is required; MS is preferred and a PhD is a plus. Candidates must have at least 6 years' experience as a technical subject matter expert in biologic analytical IND/BLA submissions and demonstrate hands-on experience with advanced testing techniques such as MS, SEC MALS, NMR, and other biophysical assays.

Physical Demands and Work Environment

This role requires up to 25% travel including international trips to India. Work can be remote, in-office, or hybrid. Physical requirements include moderate activity and lifting up to 25 pounds.

Key skills/competency

• Analytical Method Development
• Validation
• cGMP
• FDA Regulations
• Biologics
• Contract Management
• Root Cause Analysis
• Biophysical Assays
• Team Leadership
• Regulatory Submissions