Formulation Development Scientist II Resume Example
Development Scientist with a Master's degree and over 3 years of successful experience in Formulations and a good knowledge of Analytical techniques. Skilled in product development and scale-up with in-depth knowledge of liquid and semi-solid dosage technology
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- Developed a topical gel formulation in conjunction with a medical device for accelerated wound healing approved by the FDA
- Developed/optimized products currently undergoing Pre-Clinical and Clinical trials (phases I-II), Bioequivalence studies
Thermo Fisher Scientific Inc. – Dallas , TX
- Achieved hands-on experience in preformulation, 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
- Planned and executed manufacturing strategies for approximately 20 products including creams, ointments, gels, lotions, suspensions, solutions, suppositories, probiotics, photodynamic therapy products for pharmaceutical and cosmetic use
- Developed a sound understanding on the regulatory aspects of drug filing
- Adhered 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
- Handled client communication to discuss project updates and strategies
- Performed CMC related activities, including formulation, process development and container closure system evaluation
- Drafted methods, protocols, summaries, product development and technology transfer reports
- Project tracking and updates, as requested for assigned projects
- Worked on multiple projects simultaneously and supervised technicians in implementation of experiments
Tergus Pharma, 2810 Meridian Parkway, Suite 120 – City , STATE
- Performed physical characterization activities- pH, microscopy, rheology, viscosity, and texture analysis
- Conducted protocol driven preformulation 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
- Performed qualitative, quantitative physical and chemical testing to support GLP/GMP batch release
- Offered cross functional support to Analytical R&D department for 6 months, gaining experience in HPLC with Empower 3 software. Performed drug-excipient compatibility (DEC), solubility, freeze-thaw, short-term stability studies to provide formulation support.
- Performed annual calibrations and routine troubleshooting for lab equipment
Campbell University, 143 Main Street – City , STATE
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 State Characterization- Particle size evaluation using Malvern Mastersizer, Thermal analysis (DSC, TGA), FTIR, PXRD
Pharmaceutical Education And Research Center(PERC) – City , STATE
Managed documents and reviewed SOP's, prepared and analyzed drug solutions using HPLC and UV-Visible Spectrophotometry in a GMP regulated environment, performed Karl Fisher titrations, lab and chemical inventory management.
- Graduated summa cum laude
- Inducted into the Rho Chi Society- The academic honor society in Pharmacy
- Thesis “Study of Diffusion of Oral Antibiotics Using Onion as a Natural Membrane”
In an attempt to establish a natural alternative to the existing Caco-2 cell line for in-vitro drug permeation studies, diffusion experiments of Fluoroquinolone antibiotics through the membrane of Allium Cepa (Onion) were performed using Franz cell followed by sample analysis using UV/Vis Spectrophotometry and HPLC. Results were analyzed using JMP Software. A successful relationship was established between onion membrane permeability and Caco-2 permeability - Coursework in Advanced Experimental Design & Biostatistics, Drug Development & Pharmaceutical Regulations, Pharmacokinetics, Analytical Chemistry, Multivariate Analysis and Fundamentals of Cellular Pharmacology
- Member of American Association of Pharmaceutical Sciences (AAPS) and Parenteral Drug Association (PDA)
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Resume Overview
School Attended
- Campbell University
Job Titles Held:
- Formulation Development Scientist II
- Formulation Development Scientist I
- Teaching Assistant, Pharmaceutical Sciences
- QC Lab Assistant
Degrees
- Master of Science : Industrial Pharmacy 05/2016
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