Sr. Manager - FRD Non-Orals

Key Responsibilities

• 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.