MOUNIKA NANGINEEDI

• Lead New Product Development of topical pain relief formulations in the Consumer Healthcare Division
• Lead a multi-functional team comprising of functions within and outside R&D - formulations / analytical / microbiology / stability / scale-up / Toxicology, pre-clinical & clinical / packaging / regulatory / commercial and project management to successfully navigate the product through the development lifecycle
• Effectively managed budgeting strategy and project execution
• Proposed and supported the plan / secured CAPEX approvals to build in-house capability for manufacturing and packaging pre-clinical/ clinical and registration batches to contribute to cost and manufacturing efficiency, streamlined work flow, and company's sustainability objectives
• Resolved multiple technical and scale up issues for topical gels to shorten cycle time and achieve target CQA's which saved ~$250K by minimizing the number of batches to be manufactured and associated testing
• Hands on experience with leading a project from concept to early development to scale up (to 5000 Kg)
• Lead formula / technical risk assessments and propose appropriate controls to ensure product stability, safety and performance
• Propose and develop formulas in line with the marketing policy and consumer expectations
• Manage outsourced support activities at external CRO's /CDMO's
• Interpret data and provide recommendations, independently and as part of a team
• Support protocols, methods, summaries, product development reports and documents for FDA & EMEA feedback
• Generate, organize and report study data from internal and external sources
• Simultaneously managed several complex projects, meeting all pertinent milestones.
• Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.

• Relaunched R&D formulations labs in preparation for 5 new development projects
• Designed and executed protocols to support the development of Dry Powder Inhaler (DPI) and Metered Dose Inhaler (MDI) products
• Hands on experience with manufacture of powder blends using Turbula mixer and evaluation of finished blends for Critical Quality Attributes (CQA's) - Aerodynamic Particle Size Distribution (APSD), Delivered Dose Uniformity (DDU)
• Critically analyze, interpret and integrate experimental results with project objectives
• Cross functional collaboration with analytical / manufacturing / project management teams to achieve project goals
• Train and mentor junior scientists in product development and formulation concepts

• Achieved hands-on experience in pre-formulation, formulation and process development, technology transfer and scale-up activities
• Strong expertise in development of various topical drug products for both generics and New Chemical Entities (NCEs) from concept to completion leading to regulatory submission
• Designed and executed manufacturing strategies for approximately 20 products including creams, ointments, gels, lotions, suspensions and solutions for pharmaceutical and cosmetic use
• Developed a sound understanding on regulatory aspects of drug filing adhering to cGMP, GLP, USP-NF, ICH, OSHA, DEA standards
• Closely involved in scale-up and technology transfer activities from R&D laboratory scale, through pilot scale, to GMP manufacturing
• Experience with Change Controls, CAPA's and Root Cause Investigations (RCI's) in a manufacturing setting
• Worked on multiple projects simultaneously and supervised technicians in implementation of experiments
• Conducted protocol driven pre-formulation activities- API solubility, drug-excipient compatibility, thermal stability, short-term and long-term ICH stability and Karl Fischer titrations
• Applied Design of Experiments (DoE) to identify Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) affecting Critical Quality Attributes (CQA) of the product as a part of Quality by Design (QbD)
• Reviewed, compiled and interpreted results to identify issues and implement proper control strategies
• Offered cross functional support to In Vitro Release Testing (IVRT), In Vitro Permeation Testing (IVPT), Analytical and Quality Control departments gaining experience in handling dissolution apparatus, Franz cell and HPLC with Empower software

Assisted and conducted Industrial Pharmacy labs, graded lab notebooks and quizzes.

• Injectables - Developed solutions and suspensions in accordance with CGMP regulations employing appropriate In-process controls - monitoring environmental conditions, pH and clarity of solution, stability, bacterial endotoxins (LAL) and integrity of container closure systems. Hands-on experience with lyophilization, aseptic processing and sterilization techniques
• Oral Solids experience - Formulation and process development of immediate and sustained release tablets and capsules. Hands-on experience with various drug product unit operations- tablet blending, granulation, fluid bed drying, compression, coating, encapsulation, and final product packaging
• Pre-formulation Studies/ Solid State Characterization - Particle size determination, Solubility, Permeability, Dynamic vapor sorption analysis, Thermal analysis (Differential scanning calorimetry, Thermal gravimetric analysis), FTIR, PXRD