Manager, Manufacturing Nested Filling - 3rd Shift

About 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 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

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.

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