Sr. Manager - FRD Non-Orals

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Sr. Manager - FRD Non-Orals Date: May 26, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd 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. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less