Sr. Manager – Formulation & Process Development (557)

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

Job Description:

The Sr. Manager – Formulation & Process Development will oversee pharmaceutical product development activities from laboratory scale up till exhibit/PPQ batch manufacturing for sterile injectable products. As a formulation and process development leader, you will champion the process of site technology transfer for multiple aseptic ANDA products, site transfers, and BLA enabling product batches starting with engineering batch manufacturing till process validation/PPQ batches. The incumbent is responsible for leading the formulation and technology transfer team. This position will be headquartered at Civica’s exciting new plant to be in Petersburg, VA, [greater Richmond area].  

Essential Duties and Responsibilities:

• Establish the R&D process for technology transfer to transfer lab processes to manufacturing site to support regulatory filing batches.
• Work closely with site functions – operations, quality, engineering, validation, supply chain, procurement, and MSAT to bring new products to the site.
• Establish R&D team capability to scale up products at site, troubleshoot any issues arising during process scale up, and during the manufacturing engineering studies, shake-down runs, feasibility runs, and registration batches to support product scale up and regulatory filings.
• Lead New Product Introduction change control process and work with department functional leads for gap assessments.
• Define process to update product development reports to include scale up data from engineering and exhibit/PPQ batches.
• Lead engineering and exhibit batch manufacturing process including batch protocols, sampling, and working with manufacturing and quality team in sample management.
• Lead product transfer gap assessment, in-process control, batch record documentation, and FMEA analysis to identify critical/key process parameters.
• Represent Civica organization to establish R&D laboratory at the Civica manufacturing site including hiring R&D chemists.
• Lead and prepare FDA submission documents for formulation and process for products developed and scaled up to the site.
• Oversight and management of site technology transfer of aseptic products at the Civica site.
• Translate product development project requirements into a robust, scalable technical design.
• Resolve complex problems by applying sound engineering principles, utilizing experimental and analytical methods to a range of