MSAT Specialist

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 Manufacturing, Science and Technology (MSAT) Specialist will join the Civica, Inc. ("Civica") MSAT organization at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica's new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

The MSAT Specialist will conduct technical investigations and process support activities. Reporting to the Director, MSAT, this role will closely work with Civica's Manufacturing and Engineering teams and lead risk assessment and investigations.

Essential Duties and Responsibilities:

• Conduct investigations related to the process and perform root cause analysis.
• Collaborates with cross functional teams including Manufacturing, Quality, Validation and Engineering teams on process risk assessments and impact assessments.
• Write Annual Product Quality Review (APQR) and support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, and management notifications.
• Perform process troubleshooting during tech transfers and commercial manufacturing.
• Writes and reviews technical documents (SOPs, protocols and reports)
• Involves in activities related to new product introduction to the site.
• Provide support to equipment, facilities and utilities qualification, as needed.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.

Basic Qualifications and Capabilities:

• Bachelor's degree in a scientific discipline with 7+ years cGMP experience in the sterile pharmaceutical industry.
• Understanding of Quality Management System at pharma manufacturing site.
• Strong interpersonal and written communication skills.
• Excellent problem-solving and troubleshooting skills.
• Strong project management, organization, and execution skills to manage multiple projects and priorities.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Committed to delivering high quality results.
• Ability to work effectively in a team-oriented environment

Preferred Qualifications:

• Technical expertise in sterile pharmaceutical industry with experience in isolator technology and knowledge of sterilization equipments are highly preferred.
• Basic understanding of microbiological aspects of the process and products.

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions.

• Capable of working in office settings in front of computer/laptop with long sittings.
• Occasional entry to manufacturing and clean rooms is required.
• Travel (up to 10%) may be required.