Associate Director, Drug Product Development
: Job Details :

About Civica: Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports. Shortages put patients at risk and waste hospital resources. Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third 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 with essential medicines. Civica currently supplies medicines to health system members in 49 states. Civica's mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers. Civica's new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status. The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica's work to manufacture and distribute affordable medications. The Foundation's first commitment is to support Civica's efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients. Join us. Learn more at www.civicarx.org Job Description: The Associate Director of Product Development will oversee Civica's pharmaceutical product development for the various dosage forms in Civica portfolio. This role will be a hands-on technical leadership on a cross-functional project team for drug development from the early phase, scale down batch process, through scale-up including technology transfer activity support to commercialization. The responsibilities include the establishment of a development plan with strategic CMC and providing technical direction for 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 manage the preparation of the Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA) and Biologic License Applications (BLA) to support regulatory filings. This candidate will guide the formulation, process development, verification, and validation of pharmaceutical products in support of Civica's R&D portfolio of sterile injectables, oral solid dosages, and drug delivery devices as necessary. Essential Duties and Responsibilities: Lead the design and execution of drug product formulation and process development, characterization and robustness studies.Lead scale-up and technology transfer activities of products for internal and external manufacturing sites.Translate product development project requirements into a robust, scalable technical design.Resolve complex problems by applying sound engineering and product development principles, including Quality by Design (QbD) and Design of Experiments (DoE), utilizing experimental, and analytical methods to support technical product development challenges over a range of products from simple sterile injectable vial products, oral solid dosage forms 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), risk assessments, investigations, process development and implementation, Master Batch Record preparation, filtration and filling assemblies, root cause analysis for investigations and troubleshooting.Support product regulatory complete response letters, preapproval inspections, and other audits from outside agencies. The role interacts with regulatory agencies during site inspections.Understand and implement manufacturing control strategy for various product unit operation areas.Review and approve cGMP documents such as New Product Introductions to site, Product Development Reports, engineering protocols, batch records, technical reports, change controls, validation protocols, and summary reports.Represent the organization to support establishment of 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, QbD, DoE, validation requirements, vendor interactions, material, and component specifications.Work closely with both functional and project managers to identify and mitigate technical issues and manage project milestones to adhere to project timelines. Serve as designated representative for pharmacy license. Basic Qualifications and Capabilities: Bachelors, Masters, or PhD degree in pharmaceutical sciences, chemical engineering, or related disciplines with a minimum of 12 years in relevant industrial experience. Proven ability to solve critical scientific problems.Experience working in sterile injectables, biologics/Bio-Similar, and oral solid dosage forms preferred.Experience with predictive stability for new product development.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 provided 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. PandoLogic. Category: Marketing & Biz Dev, Keywords: Product Development Director