Job Description

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\xe2\x80\x99s 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\xe2\x80\x99s 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\xe2\x80\x99s 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 \xe2\x80\x9cDo What Is in the Best Interest of Patients.\xe2\x80\x9d Civica\xe2\x80\x99s 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\xe2\x80\x99s innovative model is directly impacting patient care, click to read a summary from the New England Journal of Medicine. ( )

To learn more about Civica\xe2\x80\x99s plans to bring affordable insulin to Americans living with diabetes, click to read an article in BioSpace.

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The Process Development Scientist is hands on process engineering position working on technology transfer to support process scale up for sterile injectable products. This role will be responsible for leading drug development of pharmaceuticals from engineering batches to exhibit batches till PPQ campaign as a part of new product Introduction in our state-of-the-art sterile injectable site at Petersburg, VA. As a part of the scale up, this position will also be responsible for conducting laboratory studies at our contract development lab and our R&D laboratories.

Essential Duties and Responsibilities:

• Support injectable drug product process scale up activities at Civica Petersburg site.
• Support engineering batch preparation, technology Transfer, and new product Introduction readiness activities for the site.
• Work with engineering and operations team during equipment qualification including writing custom protocols to study equipment -product fit testing, flush optimization, filter integrity testing.
• Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, aseptic processes, and container closure systems.
• Work with manufacturing during GMP production and with quality during material assessment, GMP release of raw materials and drug products in coordination with quality and extended R&D team.
• Review and assist in writing new product introduction related documents including change notifications, batch records, process development reports, tech transfer documents, and validation protocols/reports.
• Work with external vendors to finalize specifications for such as filter Provide technical support for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
• Support site leadership to build a diverse and capable technology transfer team, supporting the areas of fill and finish, filtration and filling assembly build up, device assembly, and inspection parenteral operations.
• Along with Technology transfer team, deliver technology Transfer Plan through product life cycle technology transfer, engineering, clinical, PPQ, and process validation, and control strategy development.
• Participated in and lead the development and implementation of product Failure Modes Effect Analysis (FMEA), particle investigations, filtration and filling assemblies, Root cause analysis.
• Understand and implement manufacturing control strategy for various unit operation areas.
• Translate product development project requirements into a robust, scalable technical design.
• Resolve complex problems by applying sound engineering principles, utilizing experimental, and analytical methods to a range of technical product development challenges over a range of products from simple sterile injectable vial products to more complex pre-filled syringe, pen combination products.
• Work closely with both functional and project managers to identify and mitigate technical issues, manage project milestones to adhere to project timelines.
• Work along with other R&D scientists through activities such as bench studies, pharmaceutical product development data analysis, FMEAs, combination product development, validation requirements, vendor interactions, material, and component specifications.

Basic Qualifications and Capabilities:

• Bachelor of Science Engineering or a similar technical degree. A post graduate degree is desired, but not required.
• Preferred minimum of 2 years related industry
• Experience working in FDA and DEA regulated environment.
• Working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization.
• Willingness to travel up to 10% of the time (preferred)

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