Title:  Sr. Manager - FRD Non-Orals

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.