Manager, Validation - Aseptic Process Simulation at Civica Rx

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team ofhealthcare and pharmaceutical industry leaders.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines.

Civicarecently announced plans to expand its mission, via a unit called CivicaScript,to into the outpatient pharmacy space and to manufacture and distribute insulin that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life-sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.

Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients." Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.

To find out more about how Civica's innovative model is directly impacting patient care, click here to read a summary from the NewEngland Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)

To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

Job Description:

The Manager, Validation will support Aseptic Simulation Studies performing for Sterile Products and Bio-similar products at Civica Rx, Petersburg. This role will be responsible for leading Aseptic Simulation studies from early planning, building strategies in a collaborative manner across internal disciplines and external partners and contractors.

Essential Duties and Responsibilities:

• Design and develop the Aseptic Process Simulation (APS) program for Aseptic and Biosimilar injectables.
• Conduct risk assessments and mitigate risks associated with aseptic processing operations.
• Consider multiple factors in the design of APS studies including Bracketing / Definition of Simulations / Interventions, clean room Staff qualification, Risk Base determination of Interventions, Microbiological Investigations and Environmental Monitoring as Part of the Media Fill, Incubation, Assessment and Evaluation.
• Manage the APS activities for sterile injectable vials, cartridges, pre fill syringes, and pens.
• Share knowledge and expertise with respect to start up and validation including utilities and equipment.
• Drive enhancement of sterile standards within the manufacturing environment. Resolve complex problems by applying sound sterile operation principles, utilizing knowledge from FDA & European regulatory guideline, PDA and Annex 1 requirement.
• Investigate Deviations and conduct Root Cause Analysis.
• Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
• Support product preapproval inspection. The role has direct interaction with regulatory agencies during site inspections.
• Understand and implement manufacturing control strategy for various unit operation areas.
• Define enabling studies necessary for product submission and conduct those internally and externally with collaboration from different departments.

Basic Qualifications and Capabilities:

• Bachelor's degree in microbiology, engineering, or a related discipline.
• 8+ years in a sterile cGMP production environment.
• Direct experience with APS including knowledge of the requirements of Annex 1 and PDA technical reports.
• Must have extensive hands-on experience in the development of aseptic programs including Clean Room Qualification, and Environmental Monitoring.
• Experience with biological production processes.
• Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization.

Preferred Qualifications:

• A post graduate degree is preferred.
• Experience with cleaning validation strongly preferred.
• Direct interaction experience with regulatory agencies.