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 Position Summary The Manufacturing Specialist Line Lead will play a part in the facility start-up with primary responsibilities focused on leading daily manufacturing activities on the floor, performing routine equipment, production, and line activities, and the timely production of pharmaceuticals at the Civica Petersburg, VA site. In collaboration with stakeholders, this position will support cross-functional teams with manufacturing production execution, running equipment, new product introductions, equipment qualifications, investigations, training, and development of new colleagues and line personnel. The ideal candidate will have a consistent track record of achieving results in a fast-paced, sterile manufacturing environment and maintaining a positive culture. Essential Duties and Responsibilities
- Led the day-to-day production activities on the line, responsible for aligning and scheduling personnel and resources to meet the daily and weekly production and equipment demands.
- Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety, and other cross-functional teams to meet production needs.
- Support the onboarding and technical training of Manufacturing Operators on process equipment, including high-speed fill lines with integrated Isolators, Terminal Sterilizers, ATEC commodities processing, Parts Washers, Autoclaves, Single-Use Technology, and Aseptic Process Simulations (media fills).
- Assist R&D and MSAT on new product introduction and tech transfer activities to ensure a steady stream of products to meet commercial demand.
- Initiate and complete manufacturing investigations, including root cause analysis and product impact assessment.
- Assist in the revision and management of manufacturing documents such as Batch Records and SOPs.
- Provide technical expertise and support to production teams, addressing issues and challenges as they arise while working closely with Engineering and other support teams.
- Supports regulatory inspections.
- Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions to minimize impact on operations.
Basic Qualifications (Knowledge, skills, and abilities)
- A minimum of four+ years' experience in biopharmaceutical manufacturing in a GMP environment.
- An associate's degree or higher in Pharmaceutical Sciences, Biology, or a related field is preferred.
- Experience with sterile fill-finish manufacturing.
- Knowledge of GMP, regulatory requirements, and industry best practices.
- Detailed-oriented with a focus on accuracy in creating and updating production documents.
- Ability to work autonomously and within established guidelines, procedures, and practices.
- Experience in a process improvement environment, including change management.
- Experience in using ERP systems.
- Strong communication and collaboration skills, committed to meeting high-quality standards.
- Experience performing as a shift lead of a team, training others, and developing training material.
Preferred Qualifications
- Knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
- Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
- Proficiency in Microsoft Office Suite.