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Manager, MSAT
Location:
Petersburg
Description:
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 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. You will collaborate closely with R&D and develop, transfer, execute, and improve technical transfer processes to meet project and business objectives. Essential Duties and Responsibilities: • Lead the transfer of production processes and technologies from R&D into site operations.• Responsible for developing process control strategy document, technology transfer change controls, engineering, clinical, 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, protocol development, authoring, training, and execution support, process troubleshooting, and on-the-floor hyper care 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 with regards to process control strategy (post-approval) process/yield improvement, process knowledge management, batch deviations, and ensuring accuracy of regulatory CMC registration detail.• Support product pre-approval inspection, including direct interaction with regulatory agencies during site inspections.• Prepare and review, as needed cGMP documents such as batch records, technical protocols and reports, change controls, deviation reports, validation protocols, and summary reports.• Work with operations and validation team to prepare aseptic core package for submissions.• 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.• 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.• Work closely with operation and R&D team to perfrom gap assessment for new product introduction and provide innovative solutions and develop control strategy.• Charter cross functional tech transfer teams comprising of 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 Engineering or a similar technical degree. A post graduate degree is desired, but not required.• Minimum of +6 years’ experience in technical transfer and process validation.• Experience working in FDA regulated environment.• Experience working in 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 must be met by an employee 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 duties of this position, the employee is regularly required to talk or listen. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk; sit; and reach with hands and arms. Furthermore, the employee must be capable of successfully passing aseptic gowning requirements, procedures, and certification. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. NOTE This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.
Company:
Civica Rx
Posted:
April 30 on HireLifeScience
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