Head R&D Pharmaceutical Projects
Over 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 here to read a recent article from the New England Journal of Medicine.
Intro to Civica
As Civica’s Head of Pharmaceutical Projects you will work with Contract Development Organizations to manage and direct the development of ANDA/BLA products for Civica’s manufacturing site, and other biopharmaceuticals as requested. Reporting to the Chief Research & Development Officer, you will help lead and support the R&D organization’s Product and Analytical Development projects including support for clinical supplies manufacturing and development of autoinjector pen device. 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, oral solid dosage and other dosage forms including ANDA and BLA products. This position can be headquartered at theCivica location in Lehi, Utah or remote.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Lead and support management for R&D projects including product development activities capable of formulating products, developing analytical methods, manufacturing registration batches to support a variety of dosage forms and ANDA and BLA regulatory filings.
- Oversight and management of the development of ANDA aseptic products at contract development organizations and the Civica Petersburg site.
- 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 and other dosage forms as necessary.
- Work closely with both project leaders to identify and mitigate technical issues, manage project milestones to adhere to project timelines.
- Support clinical programs for products requiring clinical BE studies and clinical supplies manufacturing.
- Improve product development cycles and quality via the application of Quality by Design and Lean Product Development Tools.
- Deliver on new drug solutions as a technical leader on a cross-functional project team through all phases of the project lifecycle, from concept through launch.
- Establish a Quality Culture into the R&D product development organization and personnel.
- Develop and guide technical design/methodologies to achieve success in developing combination products.
- Mentor other R&D associates in best development practices, analysis, simulation and verification of systems
- 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.
- Mentor and motivate team members and junior associates while coaching them through activities such as bench studies, pharmaceutical product development data analysis, FMEAs, combination product development, documents supporting ANDA and BLA filings, validation requirements, vendor interactions, material and component specifications.
MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)
- Must have a BS in Engineering or similar technical degree. A post graduate degree is desired, but not required.
- 20+ years relevant work experience (may be a combination of work experience and advanced degree education) – with sterile injectable, oral solid, and biologic dosages forms for ANDA/BLA products
- Demonstrated track record of management and leadership experience within Product Development
- Strong verbal and written communication skills
- Experience working in FDA and DEA regulated environments
- Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing and commercialization.
- Proficient knowledge and use of statistical analysis, and project management software (Primavera).
- Apply and assert regulatory compliance best practices on all projects
- Be an agile learner, tolerant of risk, and biased towards action
- Effectively mentor and clearly communicate concepts, ideas and knowledge to R&D employees, teams and customers
- Ensure compliance with quality policies, procedures and practices as well as with all local, state, federal and safety laws, policies and procedures
- Willingness to travel up to 20% of time