About Civica
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 of healthcare 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.
Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins 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 New England 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 Director, MSAT will lead technical transfer and process support activities for sterile injectable generics and biosimilars for the Civica Petersburg site. Reporting to the Petersburg Site Head/GM, you will build the site’s technology transfer and process support team. Under your leadership, you will collaborate with Pharmaceutical Development to successfully transfer and support Civica’s Research and Development (R&D) portfolio of sterile injectables products. You will extensively collaborate with R&D and operations to develop, transfer, execute, and improve robust technical transfer processes to meet project and business objectives.
Essential Duties and Responsibilities:
- Direct the transfer of sterile injectable production processes and technologies from R&D into site operations.
- Build a small but capable organization of process engineers/scientists to transfer manufacturing processes from R&D to operations. These engineers provide process stewardship throughout lifecycle management of commercial manufacturing processes. This includes initial manufacturing batch record (MBR) creation, protocol development, authoring, training, and execution support, process troubleshooting, and on-the-floor hypercare as needed.
- 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.
- Co-Own the site tech transfer process and SOP with R&D. Charter cross functional tech transfer teams comprising of R&D, QA, QC, Regulatory Affairs, and operations.
- Work with site leadership team to build subject matter expertise across functions in the areas of compounding, sterilization, and single-use assemblies for filtration and filling, device assembly, and visual inspection.
- Accountable for site process control strategy document, technical transfer change controls and protocols (with R&D) and ensuring that the manufacturing batch record meets established conditions as defined in the CMC documentation. Accountable for product life cycle technology transfer, engineering, clinical, exhibit, PPQ/process validation, and control strategy development.
- Support product preapproval inspection, including direct interaction with regulatory agencies during site inspections.
- Review and approve cGMP documents such as batch records, technical protocols and reports, change controls, deviation reports, validation protocols, and summary reports.
- Work closely with both functional and project managers to identify and mitigate technical issues and manage project milestones to adhere to project timelines.
- Serve as a key member of the site leadership team by supporting site initiatives, providing input to the site strategic direction, and supporting matrix leadership across other core business functions.
- Oversee product technical lifecycle management with regards to process control strategy (post-approval) process/yield improvement, process knowledge management, batch deviations, and ensuring accuracy of regulatory CMC registration detail.
- 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 Engineering or a similar technical degree. A post graduate degree is desired, but not required.
- Preferred minimum of 8 years related industry experience including leading teams involved in process transfer (it may be a combination with advanced degree education).
- Experience working in FDA regulated environment.
- Experience working in parenteral operations facility.
- Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization
- Strong interpersonal, collaboration and leadership skills
