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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 4 years of successful experience in Formulation and 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
  • Design of Experiments (DOE) and Statistical Analysis using JMP software
  • Technology transfer/Scale-up operations
  • Quality, cGMP, SOP, FDA, ICH regulations
  • Microsoft Word, Excel, Power Point, Project, Sharepoint
  • Adaptability, Decision-making, Strong work ethic
  • Brand and OTC products
  • 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)
Accomplishments
  • Developed a topical gel formulation in conjunction with a medical device for accelerated wound healing approved by the FDA
  • Independently developed/optimized multiple products currently undergoing Pre-Clinical and Clinical trials (phases I-II), Bioequivalence studies
Work History
Scientist, Inhalation Product Development 07/2020 to Current
Catalent Inc. – Morrisville, NC
  • Draft analytical and formulation protocols to support the development of Dry Powder Inhaler (DPI) and Metered Dose Inhaler (MDI) products
  • Conduct pre-formulation and formulation studies including solubility, blend feasibility and excipient compatibility assessment
  • Launch formulation labs from a state of dormancy
  • Independently working on projects with aggressive timelines to develop active COVID cough therapies
Formulation Development Scientist II08/2016 to 05/2020
Tergus Pharma – Durham, NC
  • 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
Teaching Assistant, Pharmaceutical Sciences08/2015 to 05/2016
Campbell University – Buies Creek, NC

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

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.

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

  • Catalent Inc.
  • Tergus Pharma
  • Campbell University
  • Pharmaceutical Education And Research Center(PERC)

School Attended

  • Campbell University

Job Titles Held:

  • Scientist, Inhalation Product Development
  • Formulation Development Scientist II
  • Teaching Assistant, Pharmaceutical Sciences
  • QC Lab Assistant

Degrees

  • Master of Science : Industrial Pharmacy 05/2016

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