Principal Engineer Formulation Process Development 557

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 market-based nonprofit established 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, the Department of Defense, and the U.S. Strategic National Stockpile, serving health system members in 49 states.

The mission has expanded to CivicaScript, which makes outpatient generic medicines affordable and accessible, working with manufacturing partners and payors to pass savings to consumers.

Civica's new 140,000 sq ft manufacturing facility in Virginia will produce sterile injectables in shortage and biosimilar insulins, ensuring affordable access for all Americans.

The Civica Foundation, a 501(c)(3), supports efforts like bringing affordable insulin to all Americans, partnering with leaders across the diabetes ecosystem.

Civica advocates for patients over profits, aiming to eliminate shortages and stabilize prices for the benefit of patients.

Learn more at www.civicarx.org

Job Description :

The Principal Engineer – Drug Product Formulation & Process Development will lead pharmaceutical development for sterile injectables, overseeing projects from early phase to commercialization, including technology transfer activities. This role is based at Civica's new plant in Petersburg, VA.

Essential Duties and Responsibilities :

• Design and develop drug formulations and processes, including characterization and robustness studies.
• Lead scale-up and technology transfer for manufacturing studies.
• Troubleshoot issues during scale-up, manufacturing, and registration batches.
• Manage change control processes and collaborate with department leads.
• Author and review process documentation and batch records.
• Lead development of manufacturing processes, batch protocols, and sampling plans.
• Participate in risk assessments, investigations, and process validations.
• Prepare CMC sections for regulatory filings like ANDA, NDA, and BLA.
• Support the establishment of R&D laboratories and hire process scientists.
• Oversee site technology transfer and resolve complex technical problems.
• Mentor team members, coach through studies, data analysis, and validation.
• Stay current with aseptic technology and support validation activities.
• Deliver innovative drug solutions through all project phases.
• Develop methodologies for combination products and improve processing technologies.

Basic Qualifications and Capabilities :

Physical Demands and Work Environment :

This role requires talking, hearing, manual dexterity, and occasional lifting up to 25 pounds. Ability to pass aseptic gowning and certification is necessary. The environment is generally low to moderate noise level.

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