Assoc Dir, Drug Product Development Biologics/Biosimilars

About Civica:

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica's plans and progress at www.civicarx.org

Job Description:

The Associate Director of Product Development for Biologics/Biosimilars will oversee Civica's pharmaceutical product development for Biosimilar products, starting with insulin analogs in vials and pen configurations. This role will lead drug development from early phase, scale down batch process through technology transfer to commercialization. The responsibilities include establishment of a development plan with strategic CMC and provide technical direction for the successful product development. The position will plan, execute drug product development, and collaboratively perform CMC strategies across internal disciplines and external partners, including contractors. Additionally, the position will oversee the preparation of the Investigational New Drug Applications and Biologic License Application (BLA) documentation to support regulatory filings. This candidate will guide the design, development, verification, and validation of pharmaceutical products in support of Civica's R&D portfolio of sterile Biosimilar injectables. The position will be based in the greater Richmond area.

Essential Duties and Responsibilities:

• Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
• Lead scale-up and technology transfer activities of bioproducts to internal and external manufacturing sites.
• Translate product development project requirements into a robust, scalable technical design.
• Resolve complex problems by applying sound engineering product development principles, including Quality by Design (QbD) and Design of Experiments (DoE), 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 - disposable auto-pen injector combination products.
• Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management.
• Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
• Deliver Technology Transfer Plan through product life cycle of technology transfer, engineering, clinical, PPQ, and process validation, and control strategy development.
• Participate in and lead the development and implementation of product Failure Modes Effect Analysis (FMEA), particle investigations, process development and implementation, Master Batch Record preparation, filtration and filling assemblies, Root cause analysis for investigations and troubleshooting.
• Support product regulatory preapproval inspections and other audits from outside agencies. The role has direct interaction with regulatory agencies during site inspections.
• Understand and implement manufacturing control strategy for various unit operation areas.
• Review and approve cGMP documents such as Product Development Reports, engineering protocols, batch records, technical reports, change controls, validation protocols, and summary reports.
• Represent the organization to establish an R&D laboratory near the Civica manufacturing site including hiring of R&D process scientists as necessary.
• 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, validation requirements, vendor interactions, material, and component specifications.

Basic Qualifications and Capabilities:

• Bachelors, Masters, or PhD in pharmaceutics, pharmaceutical sciences, chemical engineering, or related disciplines with 12 years in relevant industrial experience.
• Proven ability to solve critical scientific problems.
• Experience with biologics (proteins, conjugates, peptides and/or neurotoxins) and/or genetic medicine (AAV, LNPs, cell therapy) formulation and process development.
• Experience working in sterile injectables, specialty Bio-Similar preferred.
• Experience with predictive stability for bioproducts.
• Experience with the Design of Experiments (DoE), multivariate statistical analyses, and data visualization tools.
• 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)

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or listen. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit; and reach with hands and arms. Furthermore, the employee must be capable of successfully passing aseptic gowning requirements, procedures, and certification. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is typically low to moderate.