Supervisor - Manufacturing Prep and Fill 2nd Shift
2 months ago
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 Supervisor, Manufacturing Prep and Fill will play a part in the facility start-up, with primary responsibilities focused on supporting daily manufacturing operations and the timely production of pharmaceuticals at the Civica Petersburg, VA site. In collaboration with stakeholders, this position will lead day-to-day Manufacturing Prep and Fill responsibilities on the 2nd shift, overseeing and running all equipment, supporting new product introductions, equipment qualifications, change management, investigations, training, and development. 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.
Essential Duties and Responsibilities:
- Lead the Prep and Fill Operations team to execute daily and weekly production schedules to meet operations objectives.
- Conduct daily shift meetings to communicate current events and issues and solicit team feedback.
- Monitor team productivity and resolve immediate production needs to facilitate efficiency. Coordinate the team's break and lunch periods to minimize production downtime.
- Manage daily and weekly staffing requirements to account for absent personnel (PTO) to satisfy production needs. Coordinate overtime scheduling as needed.
- Monitor the inventory of department supplies. Report any quality issues and shortages to prevent production interruptions.
- Conduct training and ensure staff training is documented, current, and follows cGMP requirements.
- Review batch records, cycle reports, and other manufacturing documentation to identify and address any potential quality issues.
- Perform and/or oversee batch accountability calculations and final batch quantity confirmations.
- Provide immediate support in the identification and documentation of deviations and discrepancies.
- Assist in the development and update of manufacturing procedures and training material.
- Support cross-departmental activities, including maintenance, qualification, testing, and investigational activities.
- Assist R&D and MSAT on new product introduction and tech transfer activities 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.
- Perform other duties as assigned.
Basic Qualifications and Capabilities:
- 8 years experience in a GMP manufacturing environment. Prep and Fill operation experience preferred.
- 2 years of supervisory experience in GMP manufacturing.
- Associate's degree, or 8 years of cGMP production experience and knowledge, may be considered.
- 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.
Preferred Qualifications:
- Experience in a sterile fill-finish facility.
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