Manager, Manufacturing - Pen Device Assembly (518) - Civica Rx

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

Job Description

The Pen Device Assembly Manager will play a key part in the facility start-up up with primary responsibilities focused around supporting the cartridge line operations and the timely production of pharmaceuticals at the Civica Petersburg, VA site.  The Pen Device Assembly Manager is responsible for overseeing the assembly process of medical pen devices, ensuring high-quality production, efficiency, and compliance with regulatory standards. This role requires a strong background in manufacturing, particularly in medical devices, and excellent leadership skills to manage assembly teams. In collaboration with stakeholders, this position will lead day-to-day Pen Assembly Operations, overseeing and running 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:

• Oversee daily assembly operations of pen devices
• Develop and implement production schedules to meet demand
• Optimize assembly processes for efficiency and quality
• Monitor production metrics and KPIs, implementing improvements as needed
• Ensure compliance with FDA, ISO, and other relevant regulatory standards
• Collaborate with Quality Assurance team to address any quality issues, implement and maintain quality control processes.
• Manage, train, and develop assembly team members
• Ensure adherence to safety protocols and procedures
• Foster a culture of continuous improvement and innovation
• Conduct performance evaluations and provide feedback to team members
• Work closely with procurement to ensure timely availability of components
• Collaborate with logistics for efficient distribution of assembled devices
• Participate in new product development and process improvement initiatives
• Prepare and present regular reports on production performance, quality metrics, and team productivity
• Review batch records, cycle reports, and other manufacturing documentation to identify and address any potential quality issues.
• Provide immediate support in the identification and documentation of deviations and discrepancies.
• 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.

Basic Qualifications and Capabilities:

• Bachelor's degree in Life Science, Engineering, Manufacturing, or related field
• 5+ years of experience in manufacturing management, preferably in medical devices
• 8+ years of demonstrated ability in a cGMP production environment.
• Strong knowledge of FDA regulations and ISO standards for medical device manufacturing
• Excellent leadership and team management skills
• Strong problem-solving and analytical skills
• Proficiency in lean manufacturing principles and Six Sigma methodologies (certification preferred)
• Experience with ERP systems and production management software
• Experience in a sterile-fill finish facility is preferred.
• Ability to perform mathematical calculations that include exponents, scientific notation, orders of operation, algebra, and unit conversion. 
• Proficiency in Microsoft Office applications.

Preferred Qualifications:

• Experience with Pen Devices Assemble and/or Medical Devices with emphasis on sterile and aseptic environment  

Position ID: 518 - Onsite