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
Job Description:
The Manager, Manufacturing, Science and Technology (MSAT) will lead the technical transfer and process support activities for New Product Introduction for the Civica Petersburg site. Reporting to the Director, MSAT, you will work with Civica's manufacturing and engineering teams and lead technology transfers for small molecules and support transfers of biologics. You will collaborate closely with R&D 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 production processes and technologies for small molecules from R&D into site operations.
- Responsible for developing process control strategy document, technology transfer change controls, engineering, clinical, exhibit, and PPQ batch protocols in coordination with R&D and ensuring that the manufacturing batch record meets established conditions as defined in the CMC documentation.
- Responsible for process stewardship throughout lifecycle management of commercial manufacturing processes. This includes initial manufacturing batch record (MBR) creation, authoring protocols/reports, training, and execution support, process troubleshooting, and on-the-floor hyper care, as needed.
- Design Process Performance Qualification (PPQ) plan to demonstrate that the manufacturing process is performing as expected to initiate commercial manufacturing.
- Develop Continuous Process Verification (CPV) for the site.
- 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.
- Support product pre-approval inspection, including direct interaction with regulatory agencies during site inspections.
- Understand the scientific principles for manufacturing parenteral drug products, visual inspection, container closure integrity testing and packaging operations.
- Work with the site leadership team to build subject matter expertise across functions in compounding, sterilization, single-use assemblies for filtration and filling, device assembly, and visual inspection.
- Work closely with Operations and R&D teams to perform gap assessments for new product introductions, provide innovative solutions, and develop control strategies.
- Charter cross-functional tech transfer teams comprising R&D, QA, QC, Regulatory Affairs, and operations.
- Provide technical leadership for the rapid resolution of technical issues impacting supply through product performance investigations and use of root cause analysis (RCA) tools and appropriate Corrective and Preventative Actions (CAPA) and escalate key site technical issues.
Basic Qualifications and Capabilities:
- Bachelor of Science in Engineering or a similar technical degree. A postgraduate degree is desired but not required.
- Minimum of 8+ years' experience with 6 years of experience in technical transfer and process validation.
- Experience working in an FDA-regulated environment.
- Experience working in a parenteral facility operations setting.
- Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization
- Strong interpersonal, collaboration, and leadership skills
Physical Demands and Work Environment:
The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions.
While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee must frequently use hands or fingers and handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually low to moderate.
The company is an Equal Opportunity Employer, a drug-free workplace, and complies with ADA regulations as applicable.