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||Petersburg, VA United States
|| Biotechnology and Pharmaceutical
Head of Pharmaceutical Development |
Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company created by hospital systems and philanthropies, Civica's mission is to reduce and prevent drug shortages while assuring quality generic medicines are accessible and affordable to everyone.
Because the United States experiences chronic shortages of essential generic medicines used daily in hospitals, we are building a state-of-the-art sterile injectable manufacturing facility to combat these shortages. This new facility is part of our broad strategy to stabilize the supply of generic medicines for emergency rooms, surgeries, COVID-19 patient care, and an array of other serious conditions.
WHO CIVICA SERVES
While serving 50 health systems and 1,350 hospitals (or 30% of all licensed U.S. hospital beds), Civica also supplies the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and “340B” hospitals caring for vulnerable patients in some of the country's most underserved areas. And recently, Civica contributed more than 2-million vials of essential medications to the strategic national stockpile.
With 40 sterile injectable medications under contract to supply our member hospitals, Civica is growing and on track to have 100 drugs under contract by 2023.
As we continue to grow, we have many exciting opportunities for multiple types of roles and with opportunity to progress YOUR career as a Head of Pharmaceutical Product Development at our new greenfield sterile fill manufacturing site in Petersburg, VA (just outside of Richmond).
As Civica's Head of Pharmaceutical Product Development you will work with Contract Development Organizations to manage and direct the development of ANDA products for Civica's manufacturing site including the creation and oversite of the R&D team in a hands-technical leadership role. Reporting to the Chief Research & Development Officer, you will select and build the organization's Product Development and Analytical Development team. Under your leadership, you will guide the design, development, verification and validation of pharmaceutical products in support of Civica's R&D portfolio of sterile injectable, and other dosage form ANDA products. This position will be headquartered at Civica's exciting new plant to be located in Petersburg, Virginia.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Establish and lead R&D team capable of formulating products, developing analytical methods, manufacturing registration batches to support ANDA regulatory filings.
Oversight and management of the development of ANDA aseptic products.
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 combination products and oral solid dosage forms.
Guide multi-function teams comprising of QA, Regulatory Affairs, Hospital network partners, Contract Development and Manufacturing operations team members by facilitating effective communication and engagement.
Qualifications & Requirements
Bachelor of Science Engineering or a similar technical degree. A post graduate degree is desired, but not required.
Preferred minimum of 20 years related industry experience (it may be a combination with advanced degree education).
Experience working in FDA and DEA regulated environment.
Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing and commercialization.
Willingness to travel up to 20% of the time (preferred)
Salary DOE. Excellent Benefits
Over the past two decades, shortages of generic, injectable drugs critical to the lifesaving work of hospitals in the United States have become commonplace. These drug shortages are so ubiquitous that hospitals and health care systems now maintain permanent drug shortage response teams that seek alternatives to unavailable drugs.
As a result, time that hospital pharmacists, technicians, nurses and others would prefer to spend caring for patients is spent ensuring that the patients who most need short-supply drugs get whatever supply is available.
Civica was created to reduce and prevent drug shortages and the price spikes that can accompany them. Its mission is to make quality generic medicines accessible and affordable to everyone.
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