Manufacturing Specialist – Vial Line (340) - Civica Rx

About Civica

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. 

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines. 

Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.

Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.

To find out more about how Civica’s innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)

To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

Position Summary 

The Manufacturing Specialist 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.  In collaboration with stakeholders, this position will support cross-functional teams with manufacturing production execution, running equipment, new product introductions, tech transfer, equipment qualifications, change management, investigations, training, and development. The ideal candidate will have a consistent track record of achieving results in a face-paced manufacturing environment. 

Essential Duties and Responsibilities

• Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety and other cross-functional teams to meet production needs.
• Support onboarding and technical training of Manufacturing Operators on process equipment including high speed Vial line with integrated Isolators, Terminal Sterilizers, ATEC commodities processing, Parts Washer, Autoclaves, Single Use Technology, and Aseptic Process Simulations.
• Assist R&D and MSAT on new product introduction and tech transfer activities to ensure steady stream of products meet commercial demand.
• Initiate and complete manufacturing investigations including root cause analysis and product impact assessment.
• Assist in the creation, revision, and management of manufacturing documents such as Batch Records and SOPs.
• Provide technical expertise and support to production teams, addressing issues and challenges as they arise.
• Supports regulatory inspections.
• Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions with the intent to minimizing impact to operations.
• Onsite presence, as the role requires time on the manufacturing floor and cross-functional collaboration. 

Basic Qualifications (Knowledge, skills, and abilities)

• Associate’s degree in Pharmaceutical Sciences, Biology or related field preferred.
• A minimum of four years’ experience in biopharmaceutical manufacturing in a GMP environment
• Experience with sterile fill finish manufacturing.
• Detailed-oriented with a focus on accuracy in creating and updating production documents.
• Experience in using ERP systems.
• Knowledge of GMP, regulatory requirements, and industry best practices.
• Proficiency in Microsoft Office suite.
• Strong communication and collaboration skills, with a commitment to meeting high-quality standards. 

Preferred Qualifications

• Knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
• Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.