Head of Medical Device Development and Commercialization

REMOTE

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. (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-/)

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.

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