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Formulation Development Scientist II Resume Example

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FORMULATION DEVELOPMENT SCIENTIST II
Professional Summary

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

Skills
  • Generic and New Product Development
  • Small and Large molecules
  • NDA 505 (b)(1), 505 (b)(2), ANDA, NCE-1, Para-IV filing
  • R&D Lab and Production Equipment handling
  • Quality by Design (QBD)
  • Design of Experiments (DOE) and Statistical Analysis using JMP software
  • Quality, cGMP, SOP, FDA, ICH regulations
  • Microsoft Word, Excel, Power Point
  • Adaptability, Decision-making, Strong work ethic
Accomplishments
  • 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
Work History
Formulation Development Scientist II04/2018 to Current
Tergus Pharma, 2810 Meridian Parkway, Suite 120 – Durham, NC, 27713
  • 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
Formulation Development Scientist I08/2016 to 04/2018
Tergus Pharma, 2810 Meridian Parkway, Suite 120 – Durham, NC, 27713
  • 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
Teaching Assistant, Pharmaceutical Sciences08/2015 to 04/2016
Campbell University, 143 Main Street – Buies Creek, NC, 27506

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

QC Lab Assistant01/2015 to 01/2016
Pharmaceutical Education And Research Center(PERC) – Campbell University, 143 MainStreet, Buies Creek, NC, 27506

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.

Education
Master of Science: Industrial Pharmacy05/2016Campbell University- 143 Main Street, Buies Creek, NC, 27506
  • 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

Companies Worked For:

  • Tergus Pharma, 2810 Meridian Parkway, Suite 120
  • Campbell University, 143 Main Street
  • Pharmaceutical Education And Research Center(PERC)

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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