Supervisor, Manufacturing Support #580 (day shift)
Description:
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
Job Description
The Supervisor, Manufacturing Support (Day Shift 6:00 AM – 6:30 PM), will play a role in facility start-up and commercialization, with primary responsibilities focused on supporting daily manufacturing operations and the timely production of pharmaceuticals at the Civica Petersburg, VA site. This position will hire, develop, and support a team of manufacturing associates through equipment qualifications, identifying and improving processes, operating manufacturing equipment, and owning documentation. This position will provide new process training to 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.
Shift: 6am - 6:30pm | 2-2-3 schedule
Essential Duties and Responsibilities:
Under the Director of Manufacturing’s direction, actively participate in new equipment and process qualifications.
Demonstrated ability to act as subject matter expert in manufacturing processes, including autoclaves, parts washers, clean-in-place (CIP), and material transfer isolators (MTIs).
Serve as the escalation point for their group, take accountability and ownership for business, technical, and compliance decisions
Maintain Civica’s right to operate:
Maintain inspection readiness and serve as SME during inspection tours
Ensure staff are appropriately trained and qualified for the activities they perform prior to execution
Ensure systems and processes are properly executed and maintained to ensure staff’s safety, product quality, and continuity of supply
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, process efficiencies, or otherwise reduce manufacturing costs by using effective project management, cost control techniques, and Lean Manufacturing tools and techniques.
Mentors, coaches, and teaches Manufacturing Associates in the use of change management/control techniques to ensure timely completion of projects.
Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of the timely resolution of deviations/discrepancies related to Manufacturing.
Identify corrective and preventive actions (CAPA), lead project to completion within project timelines. Verify the effectiveness of CAPA by post-project data collection and analysis.
Demonstrated ability to act as subject matter expert in manufacturing processes, including autoclaves, parts washers, clean-in-place (CIP), and material transfer isolators (MTIs).
Flex schedule to meet commitments and achieve milestones related to projects, production, and other demands of the role.
Ability to work on-site is required
Maintain accuracy of and approve staff’s timecards
Minimum Qualifications (Knowledge, Skills, and Abilities)
Bachelor's degree with 4+ years of demonstrated ability in a cGMP FDA, cGMP, ISO, or other regulated production environment. An associate’s degree and 6 years of cGMP production experience may be considered.
Experience with Autoclaves and Parts Washers.
1+ years supervisory experience in a GMP manufacturing environment.
Experience in a process improvement environment, including change management and leading teams.
Lean Manufacturing/Six Sigma Green Belt Certification preferred.
Strong writing and documentation skills.
Self-directed with effective analytical and problem-solving skills.
Strong interpersonal, collaboration, communication, and leadership skills.
Physical Demands and Work Environment:
The physical demands described here are representative of those required to perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions.
While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee is frequently required to use their 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. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate.
The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.
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