Job DetailsAbout Civica:Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. Race to the bottom pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results. Who suffers most? Patients. Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent 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 of essential medicines. Since established, the #1 Policy for the Civica team has been Do What Is in the Best Interest of Patients. Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.Learn more about Civica's plans and progress at www.civicarx.org Job Description: The Manager, Manufacturing, Science, and Technology (MSAT) will lead the technical transfer and process support activities for sterile biologics for the Civica Petersburg site. In this role, you will support the Petersburg 'biologics program', including operational readiness for the new facility. Reporting to the Director, MSAT, you will work with Civica's manufacturing, engineering, and Quality teams and lead technology transfer for sterile biologics. You will collaborate closely with R&D/partners 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 sterile biologics production processes and technologies from R&D/partners into site operations.
- Responsible for developing biologics process control strategy document, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D/Partners and ensuring that the manufacturing batch record meets established conditions as defined in the CMC documentation.
- Responsible for process stewardship throughout the lifecycle management of commercial biologics manufacturing processes. This includes drafting and reviewing of batch records, protocols, summary reports, risk assessments, training, execution support, process troubleshooting, and on-the-floor support, 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 regarding process control strategy (post-approval), process/yield improvement, process knowledge management, batch deviations, and ensuring accuracy of regulatory CMC registration details.
- Develop and implement the CPV program for the site with support from site leadership.
- Support product pre-approval inspection, including direct interaction with regulatory agencies during site inspections.
- Work with operations and validation teams 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 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 the Operation, R&D, and other partner teams to perform gap assessments for new product introductions, provide innovative solutions, and develop control strategies.
- Provide technical leadership for the rapid resolution of technical issues impacting supply through product performance investigations and the 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 postgraduate degree is desired but not required.
- Minimum of 8 + years' experience with 6 years of sterile biologics experience.
- Preferred experience in biologics, 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, Man and leadership skills.