Manager, Manufacturing Nested Filling – 3rd Shift (509)

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.org

The Manager, Manufacturing Nested Filling, will play a part in the facility start-up with primary responsibilities focused around supporting daily manufacturing operations and the timely production of pharmaceuticals at the Civica Petersburg, VA site. The Manufacturing Manager will develop and support the Manufacturing team by participating in equipment qualifications, identifying and implementing process improvements through process monitoring, conducting investigations, and impact assessments. Lead the manufacturing team to achieve efficient, cost-effective, safe, and compliant production of quality injectable products according to the Civica culture and vision of what is in the best interest of the patient.

In collaboration with stakeholders, this position will lead day-to-day Manufacturing Prep and Fill responsibilities on the 3^rd shift, overseeing and running all equipment, supporting new product introductions, equipment qualifications, change management, investigations, training, and development. The ideal candidate will have a consistent track record of achieving results in a fast-paced Pharmaceutical Sterile Fill/Finish environment. 

Essential Duties and Responsibilities:

• Lead the Prep and Fill Operations team to execute daily and weekly production schedules to meet operations objectives.
• Develop and create standard operating procedures, specifications, and other forms of governing documents to delineate manufacturing process requirements according to qualification, compliance, and business requirements.
• Ensure that the Manufacturing organization operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.
• Responsible for identifying opportunities to improve customer service, quality, safety performance, scrap minimization, or otherwise reduce manufacturing costs by using effective project management, cost control techniques, and Lean Manufacturing.
• Mentors, coaches, and teaches Manufacturing Associates in the use of statistical tools, Lean/Six Sigma methodologies, and change management/control techniques.
• Conduct training and ensure staff training is documented, current, and follows cGMP requirements.
• Assist in the revision, and management of manufacturing documents such as Batch Records and SOPs. Identify and address any potential quality issues.
• Perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Manufacturing.
• Identify corrective and preventive actions (CAPA), lead project to completion within project timelines. Verify effectiveness of CAPA by post-project data collection and analysis.
• Demonstrated ability to act as subject matter expert in manufacturing equipment build and function, as well as in manufacturing processes, including aseptic filling, isolator/RABs technology, and packaging.
• Assist R&D and MSAT on new product introduction and tech transfer activities to meet commercial demand.
• Perform other duties as assigned.

Basic Qualifications and Capabilities:

• Bachelor's degree with 8 years of demonstrated ability in a cGMP production environment. An Associate degree and 10 years of cGMP production experience may be considered.
• Experience in a sterile fill-finish facility. 3 years’ supervisory experience in a GMP manufacturing environment.     
• Strong writing and documentation skills.
• Strong interpersonal, collaboration, communication, and leadership skills.
• Experience in a process improvement environment including change management, optimizing process flow, and participating in Lean/Six Sigma project teams.
• Self-directed with effective analytical and problem-solving skills.
• Interact with other functions and must be able to take ownership of and follow through on assigned projects.