About Civica:Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.Shortages put patients at risk and waste hospital resources.Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third 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 with essential medicines. Civica currently supplies medicines to health system members in 49 states.Civica's mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.Civica's new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica's work to manufacture and distribute affordable medications. The Foundation's first commitment is to support Civica's efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.Join us. Learn more at
www.civicarx.orgPosition 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.