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Head of Medical Device Development and Commercialization

Company: Civica Rx
Location: Petersburg
Posted on: August 6, 2022

Job Description:

REMOTEAbout CivicaOver the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration's shortage list. Manufacturing challenges and predatory pricing are both the cause and result. Who suffers most? Patients. 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. Led by an experienced team of health care and pharmaceutical industry leaders. Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent 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 is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been Do What Is in the Best Interest of Patients. Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs. To find out more about how Civica's innovative model is directly impacting patient care, click below to read a recent article from the New England Journal of Medicine.https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189 Video Introduction to Civica: https://vimeo.com/646267406 Position Summary Reporting to the Sr. Vice President of Biologics, the Head of Medical Device Development and Commercialization will be responsible for all activities related to development, launch, and continuing commercial supply of medical device components and drug delivery systems for both generics and biosimilar combination products at Civica. This individual will partner with device technology firms to execute human factors design, development, and commercialization activities required to achieve Health Authority approval. This individual will also lead all post-approval lifecycle management activities, including process/injection mold scale up, change control, and and maintain patient supply at an affordable cost for patients. Essential Functions

Evaluate technical elements of new drug delivery technologies and business opportunities. Support Civica leadership team to select and partner with device development and manufacturing firms.
Identify, recruit, and manage consultants and engineers to execute combination product deliverables in support of product launch.
Maintain product and process changes throughout the product lifecycle, including change assessments from our device component suppliers.
Partner with consultants, suppliers, and design contractors to ensure all elements of Design History File are executed and maintained throughout the product development and commercialization lifecycle.
Ensure Product Development and Design Transfer Plans are crafted and executed in accordance with CFR 820 and/or ISO 13485 regulations, as well as and other CMC regulatory guidance documents pertaining to combination products and pen injector systems.
Accountable for development and execution of human factors studies and design validation for Civica's combination products (e.g. insulin prefilled pens) often through partnerships with third parties. The context at Civica will be primarily biosimilar and generic products.
Leads and coordinates the activities of device subteams within product development teams.
Accountable to support Process development and transfer of combination product assembly processes, primarily cartridge and or syringe assembly into injection pens/devices.
Represent Civica as a Device expert for CMC regulatory interfaces, e.g. CDRH
Reviews and approves technical documentation pertaining to component mold qualification, user requirements specifications, design verification protocols, and other relevant deliverables.
Partner with Quality Assurance to create and maintain complaint management and investigation capability to support resolution of device-related product complaints
Perform other duties as assigned.
Minimum Qualifications (Knowledge, Skills, and Abilities)

8+ years experience in process or product engineering within the medical device, packaging, or pharmaceutical manufacturing fields. Direct experience with pen injector systems is highly desirable
BS /BA in Mechanical Engineering,life sciences, or other related technical field.
Experience in pharmaceutical operations/cGMP environment.
Demonstrated ability to effectively communicate and negotiate a diversity of issues.
Strong interpersonal and communication skills, both verbally and written, at all levels within Civica and external partner organizations.
Ability to effectively collaborate with others to achieve team goals and expectations.
Effective time management and prioritization skills.
Outstanding organization skills and attention to detail.
Self-starter, mature, independent and dependable.
Ability to work in a fast-paced environment under pressure, able to multi-task and obtain results.
Ability to maintain high degree of confidentiality and use of appropriate discretion and independent judgment.
PI187947641

Keywords: Civica Rx, Richmond , Head of Medical Device Development and Commercialization, Healthcare , Petersburg, Virginia

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