Manager, Manufacturing, Science, and Technology (MSAT) (375)

About Civica:

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. 

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at  www.civicarx.org

The Manager, Manufacturing, Science, and Technology (MSAT) will lead the technical transfer and process support activities for sterile biologics for the Civica Petersburg site. In this role, you will support the Petersburg ‘biologics program’, including operational readiness for the new facility. Reporting to the Director, MSAT, you will work with Civica’s manufacturing, engineering, and Quality teams and lead technology transfer for sterile biologics. You will collaborate closely with R&D/partners and develop, transfer, execute, and improve technical transfer processes to meet project and business objectives. The Petersburg, VA site serves as Civica’s new fill-finish facility, dedicated to manufacturing and supplying essential generic sterile injectable medications.

Essential Duties and Responsibilities:

• Lead the transfer of sterile biologics production processes and technologies from R&D/partners into site operations.
• Responsible for developing biologics process control strategy document, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D/Partners and ensuring that the manufacturing batch record meets established conditions as defined in the CMC documentation.
• Responsible for process stewardship throughout the lifecycle management of commercial biologics manufacturing processes.  This includes drafting and reviewing of batch records, protocols, summary reports, risk assessments, training, execution support, process troubleshooting, and on-the-floor support, as needed.   
• Design Process Performance Qualification (PPQ) plan to demonstrate manufacturing process is performing as expected to initiate commercial manufacturing. 
• Oversee product technical lifecycle management regarding process control strategy (post-approval), process/yield improvement, process knowledge management, batch deviations, and ensuring accuracy of regulatory CMC registration details.
• Develop and implement the CPV program for the site with support from site leadership.
• Support product pre-approval inspection, including direct interaction with regulatory agencies during site inspections.
• Work with operations and validation teams to prepare aseptic core package for submissions.
• Understand the scientific principles for manufacturing parenteral drug products, device assembly, and packaging,