Amanda Roden Email & Phone Number

Kansas City, Mo, Us

Project manager for new drug development programs responsible for planning and managing execution of the full development process for a product including CMC, clinical, and regulatory activities. Collaboration with internal and external stakeholders (CMOs and CROs) to define program strategy, execute to project milestones and decrease risks. Encourage knowledge sharing across teams to drive consistency among programs and implement standard ways of working. Develop and maintain program budgets by working with team members to define required activities, requesting and executing contracts, reviewing invoices, and providing monthly tracking and updates.

• Leading cross-functional teams to complete development and commercialization of combination products. Includes identifying and meeting key milestones, identifying and mitigating potential risks, risk communication to stakeholders as needed, and ensuring filing timelines are met.

• Authored sections of Biological Licensing Applications (3 separate filings), Type C pre-meeting packages, as well as technical responses for information requests from the FDA. • Led cross-functional teams to complete development and commercialization of combination products. Including BLA submission within 9 months of project endorsement.• Led collaboration activities with external partners and contract manufacturing organizations.• Established a control strategy for the prefilled syringe combination products to support production of future commercial manufacturing. Authored technical memos and performed statistical data analysis to support defined controls system.• Lead Device Engineer during design and process transfer activities to transition 2 prefilled syringe combination products from the clinical to commercial production phase in support of a biological licensing application.

• Authored 21 CFR 820.30 compliant design control documents for multiple projects, led stage gate design reviews, and execution of design verification testing. • Led clinical complaint investigations and authored technical summary reports to summarize findings. Included working with Clinical Operations to improve the communication and process around clinical complaints reporting process.• Supported collaboration activities with external partners and contract manufacturing organizations as a subject matter expert.

• Identified new techniques for test methods for characterizing and measuring critical device attributes (e.g. needle ID, silicone extraction, tactile pressure sensors).• Initiated contact with vendors to discuss equipment capabilities, complete proof of concept testing, as well as, procure new equipment. e.g. TekScan tactile pressure sensors and sample processing via wire EDM (electrical discharge machining) and electropolishing.• Collaborated with statisticians and colleagues to design, perform, and analyze test method validation studies using Gage R&R and ANOVA methods.• Authored technical memos and/or reports to summarize experimental findings, as well as, device test method documents for new and/or optimized methods.