Malone Carmel
About Malone Carmel
Malone Carmel is a Project Manager at Alkermes in Athlone, Ireland, with over 20 years of experience in the pharmaceutical industry, specializing in Project Planning & Management, Analytical Chemistry, and Technology Transfer.
Current Title and Role
Malone Carmel currently serves as a Project Manager at Alkermes in Athlone, Ireland. In this role, she is responsible for managing cross-functional activities within CMC teams for the development of proprietary pharmaceuticals. She partners with CMC team members and R&D Senior Management to ensure proper execution of CMC plans, timelines, budgets, and project plans. Her duties span various CMC areas, including API development, drug formulation, process development, and CMC regulatory compliance.
Previous Positions in Pharmaceuticals
Before her current role at Alkermes, Malone Carmel worked as a Validation Analyst at Pfizer Pharmaceuticals, Pottery Road, Dublin for a period of 9 months in 1995 and 1996. Prior to that, she was employed as a Laboratory Analyst at Newport Pharmaceuticals, Baldoyle, Dublin from 1992 to 1994, where she gained valuable hands-on experience in analytical chemistry and laboratory processes.
Educational Background and Certifications
Malone Carmel has a strong educational background, consisting of a Bachelor of Science (BSc) Hons in Analytical Chemistry from the Dublin Institute of Technology, completed from 1989 to 1992. She further enhanced her expertise in project management by studying Strategic Project Management at the Institute Project Management Ireland, where she achieved an IPMA- Level C certification in 2014 after an 11-month course.
Experience in Pharmaceutical Industry
With over 20 years of experience in the pharmaceutical industry, Malone Carmel has a deep understanding of Project Planning & Management, Analytical Chemistry, and Technology Transfer. She has managed project transfers from multinational pharmaceutical companies and streamlined data tracking processes by maintaining SharePoint sites. Her experience also includes managing study timelines for small clinical studies and assembling non-clinical data for FDA meetings.
Integration of CMC Plans and Regulatory Knowledge
Malone Carmel integrates detailed execution and long-term development plans across various CMC areas such as API development & manufacture, drug formulation, process development, analytical development, and validation. She has a working understanding of cGMP, ICH, EMA, and FDA CMC guidelines, which enables her to align with industry standards and regulatory requirements. Her role involves communicating team progress to senior management, clients, and partners, ensuring all projects meet their critical milestones and regulatory compliance.