Sr. Manager – Formulation & Process Development (557)

Join us to make quality medicines available and affordable About Civica: Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare, with over 300 medications currently reported in shortage according to industry and FDA reports. Shortages put patients at risk and waste hospital resources. Civica is a nonprofit created in 2018 by health systems and philanthropies to prevent and mitigate drug shortages. Nearly 60 health systems, representing over 1,400 hospitals and about one-third of U.S. hospital beds, have joined Civica. Civica supplies medicines to the U.S. Department of Veteran’s Affairs, Department of Defense, and the Strategic National Stockpile, currently serving health systems in 49 states. The mission has expanded to CivicaScript, which aims to make outpatient generic medicines affordable and accessible. Civica partners with manufacturers, payors, pharmacy benefit managers, and pharmacies to reduce costs and improve access. Our new 140,000 sq ft manufacturing facility in Virginia will produce sterile injectables in shortage and biosimilar insulins to ensure affordable access for all Americans. The Civica Foundation, a 501(c)(3), supports manufacturing and distribution of affordable medications, focusing initially on insulin access for Americans with diabetes. Civica champions a movement for patients, prioritizing health over profits, by addressing shortages and high prices in the industry. Position: Sr. Manager – Formulation & Process Development This role oversees pharmaceutical development from lab scale-up to manufacturing batches for sterile injectables, leading technology transfer, process validation, and team management at our Petersburg, VA facility. Essential Duties: Establish R&D processes for transferring lab processes to manufacturing for regulatory batches. Coordinate with operations, quality, engineering, validation, supply chain, procurement, and MSAT to support new product launches. Build team capabilities for product scale-up, troubleshoot during process development, and support regulatory filings. Lead change control processes, update development reports, and oversee manufacturing processes and batch documentation. Manage technology transfer, process validation, and regulatory documentation for sterile injectable products. Translate product requirements into scalable technical designs and resolve complex development issues. Collaborate with project teams to meet milestones and deliver solutions from concept to launch. Mentor team members, ensure compliance with Civica’s Code of Conduct, and perform other duties as needed. Qualifications: BSc in Engineering or related field; advanced degree preferred. Minimum 12 years industry experience, preferably in FDA/DEA regulated environments. Knowledge of pharmaceutical development standards and regulatory expectations. Willingness to travel up to 20% (preferred). Physical & Work Environment: Requires communication, manual dexterity, and ability to pass aseptic gowning. May lift up to 25 pounds. Work environment is typically low to moderate noise, with accommodations available for disabilities.

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