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JC
Jessica Claire
, , 100 Montgomery St. 10th Floor (555) 432-1000, resumesample@example.com
Professional Summary

Development Scientist with a Master's degree and over 5 years of successful experience in Formulation and Analytical techniques. Skilled in product development and scale-up with in-depth knowledge of Liquid, Semisolid and Inhalation dosage technology

Skills
  • Generic and New Product Development
  • Design of Experiments (DOE) and Statistical Analysis using JMP software
  • Preclinical and Clinical Development of Topicals and Inhalation products (DPIs & MDIs)
  • Technology transfer/Scale-up operations
  • Quality, cGMP, SOP, FDA, ICH regulations
  • Microsoft Word, Excel, Power Point, Project
  • Adaptability, Decision-making, Strong work ethic
  • Prescription and OTC products
  • Small and Large molecules
  • IND, 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 in conjunction with a medical device for accelerated wound healing approved by the FDA
  • Developed a Dry Powder Inhaler formulation within an aggressive timeline of 6 months for COVID cough therapy - currently undergoing clinical trials.
  • Independently developed/optimized multiple products currently undergoing Pre-Clinical and Clinical trials (phases I-II), Bioequivalence studies
Work History
04/2021 to Current Senior Development Scientist Danaher | Kalamazoo, MI,
  • Lead the New Product Development of topical pain relief formulations in support of Brand Innovation Strategy
  • 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
  • Generate, organize and report study data from internal and external sources
  • Collaborate with cross-functional partners to contribute to the development of consumer-driven innovation
  • Saved the company $1M per project by eliminating the outsourcing of pilot scale manufacturing by rehabilitating unused equipment in an international lab
07/2020 to 04/2021 Scientist, Inhalation Product Development Catalent Pharma Solutions, Inc. | Bel Air, KY,
  • Relaunched the 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
  • 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
08/2016 to 05/2020 Formulation Development Scientist II Tergus Pharma | City, STATE,
  • 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
  • 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 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
  • 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
  • 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
08/2015 to 05/2016 Teaching Assistant, Pharmaceutical Sciences Campbell University | 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 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
Education
Expected in 05/2016 Master of Science | Industrial Pharmacy Campbell University, Buies Creek, NC GPA:
  • 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” (manuscript approved for publication)
  • Coursework in Advanced Experimental Design & Biostatistics, Drug Development & Pharmaceutical Regulations, Pharmacokinetics, Analytical Chemistry, Multivariate Analysis and Fundamentals of Cellular Pharmacology
Expected in 05/2014 Bachelor of Science | Pharmaceutical Sciences Osmania University , Hyderabad, India , GPA:

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Resume Overview

School Attended

  • Campbell University
  • Osmania University

Job Titles Held:

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

Degrees

  • Master of Science
  • Bachelor of Science

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