Sr. Manager - FRD Non-Orals

As a seasoned professional in the field of pharmaceutical sciences, you will be responsible for providing technical expertise, strategic leadership, project management, regulatory compliance, and team development in the realm of liposomal drug products. Your primary focus will be on guiding formulation design, optimizing processes, and ensuring adherence to global regulatory requirements for liposomal generics. Utilizing a science-driven approach, you will tackle complex challenges in formulation and manufacturing to drive project success. Leading and managing R&D projects centered on liposomal formulations will be a key aspect of your role, aligning these initiatives with organizational goals and developing strategies for design, scale-up, and commercialization of complex generics. Collaboration with cross-functional teams such as Regulatory Affairs, Quality Assurance, Manufacturing, and Marketing will be essential to ensure seamless project execution. Your proficiency in project management will be put to the test as you oversee multiple R&D projects, ensuring adherence to timelines, budgets, and resource allocation. You will also be responsible for facilitating technology transfer from R&D to manufacturing, guaranteeing the establishment of robust and scalable processes. Keeping track of progress against key milestones and providing updates to senior management will be crucial in maintaining project momentum. In the realm of regulatory and compliance, you will play a vital role in supporting the preparation of ANDA submissions for complex generics, along with ensuring compliance with cGMP, GLP, and other applicable regulations during development activities. Your expertise will be instrumental in authoring and reviewing Module 3 documentation for submissions. Moreover, your leadership capabilities will be pivotal in mentoring and developing a high-performing R&D team specializing in complex drug delivery systems. By fostering a culture of innovation, collaboration, and continuous learning, you will contribute to the growth and success of the team. To excel in this role, you should hold a PhD/MS in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related fields, coupled with a minimum of 14-17 years of experience in R&D for complex generics, with a specific focus on liposomal formulations. Your track record should demonstrate successful development and commercialization of liposomal drug delivery systems, as well as proven experience in ANDA filings for complex generics. Key to your success will be a deep understanding of liposomal technology, global regulatory guidelines, and quality standards for complex generics. Your proficiency in project management, problem-solving, decision-making, leadership, communication, and interpersonal skills will be critical in driving project outcomes. Your performance will be measured based on the successful completion of R&D milestones within defined timelines and budgets, the number of successful ANDA submissions and approvals for liposomal generics, the efficiency of technology transfer processes to manufacturing, and the development of innovative formulations and cost-effective processes.,