Manager of CMC

The International Partnership for Microbicides (IPM) presents a dynamic, innovative approach to preventing HIV infection, especially in developing countries. IPM is a global, Product Development Partnership (PDP) created to speed the development of new women-initiated products that prevent HIV infection and make them available to women worldwide.

 

The Manager of CMC will:Assist with the preparation and review of CMC sections to support US and ex-US regulatory submissions (IND, IMPD, IB)Ensure the quality and completeness of documents, data, reports used to support regulatory submissions; escalates issues where timelines are criticalInteract with other IPM departments to provide regulatory/CMC information on projects/products; with supervision, participates on cross-functional project teams to provide input on stage-specific CMC regulatory requirements and/or recommendations (pre-IND, IND -PhI/II/III)Organize and maintain CMC-related documents used for regulatory submission: tracking of submission components, monitoring due dates with identification and follow-up on issues, ensuring applicable document format to best support applicable submissionsTrack pharmacopoeial updates and impact to IPM specificationsAssist with communicating CMC regulatory requirements/recommendations to ensure all development activities are in compliance with applicable regulations and guidelinesMonitor changes to development plans and impact to CMC regulatory strategy; assist with providing CMC regulatory guidance to teams to bridge changes into the clinicContribute to the development of comparability, validation, and stability protocols, drug substance and drug product specifications, and raw material specificationsHelp drive CMC submission support activitiesLiaise with CMOs to ensure regulatory compliance

 

Education, Experience and AbilitiesBS with 6-8 years relevant experience; MS with 4-6 years relevant experienceWorking knowledge of ICH Quality Guidelines; comfortable with reviewing changes to regulatory requirements and guidelines, as well as assessing potential impact to ongoing/future submissionsKnowledge of USP, EP as they relate to raw materials testing and analytical procedures (USP General Chapters, for example)Working knowledge of CTD Module 2 QOS, and Module 3 requirements for submissionStrong project management, problem solving, and communication (written and oral) skillsPrevious experience with CMC support for regulatory submissions, beyond coordination role (technical writing for submissions, experience with generating responses to regulatory inquiries regarding CMC submission information)Working knowledge of drug development process; knowledge of US and EU regulatory requirements (knowledge of RoW regulatory requirements a plus

The position is based in Bethlehem, Pennsylvania.

 

To apply, please visit http://ipm-web.ipm-microbicides.org/careers to read a full job description and apply.

 

IPM is an Equal Employment Opportunity Employer.