KMS Health Center Private Limited [KMSHC] is a partner of choice to global pharmaceutical companies in the areas of novel drug delivery systems (NDDS) development, custom pharmaceutical product development, R&D services and to support end-to-end product development of complex and niche products.
Post : Head - Formulation Development (FD)
Seeking an experienced and strategic Head - Formulation Development (FD) to lead and drive formulation development activities across oral and parenteral small molecule generic drug products. The role requires strong expertise in product development, scale-up. technology transfer, and cross-functional leadership to ensure successful progression from concept through commercialization. The ideal candidate will bring extensive experience in regulated environments, CMO collaborations, and building high- performing development teams.
Areas of Expertise
• Oral Solid Dosage Forms, Liquids and Injectables
• QbD-Based Product Development & Optimization
• Scale-Up, Technology Transfer & CMO Management
• Regulatory Submissions (ANDA/CTD) & Global Compliance
• Team Leadership, Mentoring & Talent Development
• Innovation, Lifecycle Management & Portfolio Strategy
Job Description
• Lead and oversee end-to-end formulation development programs for generic drug products including solid oral dosage forms, liquids, and injectables.
• Develop and execute formulation strategies aligned with product, regulatory, and business objectives.
• Drive pre-formulation studies, compatibility assessments, QbD-based product development, and optimization activities.
• Provide strategic leadership for scale-up and technology transfer activities to manufacturing sites and external CMOs for successful commercial execution.
• Lead and mentor formulation teams, ensuring scientific excellence, project prioritization, and efficient resource utilization.
• Collaborate with cross-functional teams including Analytical Development, Regulatory Affairs, Quality Assurance, Manufacturing, Clinical, and Project Management teams.
• Review and approve development protocols, technical reports, batch manufacturing records, and technology transfer documents.
• Support regulatory submissions including ANDA and CTD modules by providing scientific rationale and formulation-related documentation.
• Identify and resolve technical challenges related to formulation, process development, scale-up, and post-transfer commercialization activities.
• Drive continuous improvement initiatives, innovation opportunities, and lifecycle management strategies across product portfolios.
• Ensure compliance with GMP requirements, ICH guidelines, and applicable regulatory expectations.
Candidate Profile
• M.Pharm / M.S. (Pharm) / Ph.D. in (Pharmaceutics or related field.
• 12-18+ years of experience in formulation development of small molecule generic drug products.
• Demonstrated leadership experience managing formulation teams and multiple development projects.
• Strong technical, leadership, analytical, and problem-solving capabilities.
• Experience in regulated markets including USFDA. EMA and other international markets.
• Familiarity with BA/BE studies, clinical trial batch manufacturing, and regulatory expectations.
• Experience in lifecycle management, reformulation strategies, and complex generics development.
• Exposure to product commercialization and portfolio planning activities.
G. Vasanthi : vasanthi@kmshc.com
Last Date : 10th June 2026
See All B.Pharm Alerts M.Pharm Alerts M.Sc Alerts Mumbai Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
