Key Responsibilities: Technical Expertise: Provide technical guidance in formulation design, process optimization, and characterization of liposomal drug products. Solve complex formulation and manufacturing challenges using a science-driven approach. Ensure adherence to global regulatory requirements (e.g., FDA, EMA) for liposomal generics. Strategic Leadership: Lead and manage R&D projects focused on liposomal formulations, ensuring alignment with organizational goals. Develop strategies for the design, development, scale-up, and commercialization of complex generics, including liposomes. Collaborate with cross-functional teams, including Regulatory Affairs, Quality Assurance, Manufacturing, and Marketing, to ensure project success. Project Management: Manage multiple R&D projects with accountability for timelines, budgets, and resource allocation. Oversee technology transfer from R&D to manufacturing, ensuring robust and scalable processes. Track progress against key milestones and provide updates to senior management. Regulatory and Compliance: Support the preparation of ANDA submissions for complex generics, including authoring and reviewing Module 3 documentation. Ensure compliance with cGMP, GLP, and other applicable regulations during development activities. Team Development: Mentor and develop a high-performing R&D team with expertise in complex drug delivery systems. Foster a culture of innovation, collaboration, and continuous learning. Qualifications: PhD/MS in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related fields. Experience: Minimum of 14-17 years of experience in R&D for complex generics, with at least 5 years focused on liposomal formulations. Demonstrated experience in developing and commercializing liposomal drug delivery systems. Proven track record of successful ANDA filings for complex generics. Skills & Competencies: Deep understanding of liposomal technology, including formulation, characterization, and analytical techniques. Strong knowledge of global regulatory guidelines and quality standards for complex generics. Excellent project management, problem-solving, and decision-making skills. Strong leadership, communication, and interpersonal abilities. Key Performance Indicators (KPIs): Successful completion of R&D milestones within defined timelines and budgets. Number of successful ANDA submissions and approvals for liposomal generics. Efficiency of technology transfer processes to manufacturing. Development of innovative formulations and cost-effective processes. We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.