Formulation Development Scientist II Resume Example

• Achieved hands-on experience in pre-formulation, formulation and process development, technology transfer and scale-up activities
• Strong expertise in the development of various topical drug products for both generics and New Chemical Entities (NCEs) from concept to completion leading to regulatory submission
• Planned and executed manufacturing strategies for approximately 20products including creams, ointments, gels, lotions, suspensions and solutions for pharmaceutical and cosmetic use. Experience handling corticosteroids, retinoids, hormonal therapy agents
• Developed a sound understanding on the 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
• Managed processes in cGMP and pilot scale for clinical/registration and R&D batches
• Coordinated project activities between R&D, manufacturing, quality control, quality assurance, and client
• Independently handled client communication to discuss project updates and strategies
• Performed CMC related activities, including formulation, process development and container closure system evaluation
• Drafted proposals, methods, protocols, summaries, product development and technology transfer reports
• Worked on multiple projects simultaneously and supervised technicians in implementation of experiments
• Performed physical characterization activities- pH, microscopy, rheology, viscosity, and texture analysis
• Conducted protocol driven pre-formulation activities- API solubility, drug-excipient compatibility, thermal stability, short-term and long-term ICH stability
• Applied Design of Experiments (DoE) to identify Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) affecting Critical Quality Attributes (CQA) of the product
• Reviewed, compiled and interpreted results to identify issues and implement proper control strategies
• Maintenance of log books, peer review of laboratory notebooks and training new colleagues
• 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
• Performed qualitative, quantitative physical and chemical testing to support GLP/GMP batch release

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.
• Solid Orals - 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.
• Solid State Characterization- Particle size evaluation using Malvern Mastersizer, Thermal analysis (DSC, TGA), FTIR, PXRD

Managed documents and reviewed SOP's, prepared and analyzed drug solutions using HPLC and UV-Visible Spectrophotometry in a GMP regulated environment, performed Karl Fischer titrations, lab and chemical inventory management.