Supervisor, Manufacturing - Pen Assembly at Civica Rx

AboutCivica

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 ofhealthcare 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.

Civicarecently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulin 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 NewEngland 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-/)

Job Description

The Manufacturing Supervisor will play a key part in the facility start up with primary responsibilities focused around supporting the cartridge line operations and the timely production of pharmaceuticals at the Civica Petersburg, VA site. In collaboration with stakeholders, this position will lead day to day Cartridge Visual Inspection and Pen Assembly Operations, overseeing and running equipment, support 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 face-paced Pharmaceutical Sterile Fill/Finish environment.

Essential Duties and Responsibilities:

• Lead the Pen Assembly and Visual Inspection team to execute daily and weekly production schedules to meet operations objectives.
• Conduct daily shift meetings to communicate current events, 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.
• Support cross-departmental activities including maintenance, qualification, testing, and investigational activities.
• Assist in the development and update of manufacturing procedures and training materials.
• Perform other duties as assigned by manufacturing management.
• 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.

Basic Qualifications and Capabilities:

• Associate degree with 8+ years demonstrated ability in a cGMP production environment.
• High School degree with 10 years of experience of cGMP production experience may be considered.
• Experience in a sterile fill-finish facility.
• 2+ years of supervisory experience.
• Strong writing and documentation skills.
• 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 Assemble and/or Visual Inspection strongly preferred.