- For startup phase, act as Civica Operations counterpart to CMO Leadership, and person-in-plant support (PIP) for critical startup activities, always advocating for on time delivery of quality medicines in the best interest of patients and Civica.
- Facilitate communication of Civica deliverables in support of the Manufacturing Service Agreement such as demand planning. Ensure the CDMO delivers commitments based on Civica Supply Chain planning requirements.
- Proactively identify risks to supply based upon ongoing trend performance. These risks can often only be detected through periodic on-site visits.
- Work with CDMO project management and Civica program management to build tech transfer and startup schedules, and carefully manage schedule adherence.
- Participate with Civica Supply Chain in Quarterly supplier reviews.
- For startup sites, work directly with general management and staff to recommend and implement operational improvements.
- Ensure CDMO is operating within the agreed Quality agreement. Coordinate QA support resources with Civica quality to enable audit and supplier qualification.
- Prioritize resources at the CDMO, and within Civica to ensure critical products are released in a timely manner.
- Ensure CDMO site master plans and major capital upgrades are executed according to agreements and within the best interest of Civica products.
- 14 years minimum experience, 5 of which should be in a plant operations environment.
- Experience in Quality and Operations organizations within GMP manufacturing
- BS/BA level collegiate degree from accredited university
- Requires up to 50% travel to partner CDMO's, however time outside of travel can be conducted as remotely-design.
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Head of External Manufacturing - Petersburg, United States - Civica Rx
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'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. )
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
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Job Description:
This individual has accountability to manage and deliver affordable drug substance, drug product, and API from Civica's contract development and manufacturing partners (CDMO) in India and Asia Pacific region. The primary role is to actively manage manufacturing, operational, and quality performance according to those agreements during startup, tech transfer, and commercial phases. For new products and supply nodes, this individual will partner with Civica Business development, Quality, and Executive Leadership to identify and secure agreements with potential partners in the region for biologics, retail, and hospital products, and lead due diligence efforts.
As Civica partners increase over time, this individual may be required to staff a small team of consultants/contingent workers to support local quality, engineering, and subject matter experts during intense phases of startup. This may include tech transfer or Health Authority Inspection readiness.
Essential Duties and Responsibilities:
Basic Qualifications and Capabilities:
