Associate Formulation Scientist Resume Example

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(555) 432-1000,
Montgomery Street, San Francisco, CA 94105
Professional Summary

Motivated pharmaceutical professional with four years experience in a diverse range of formulation development functions. Ability to manage multiple programs with strong technical background in designing drug delivery solutions including pre-formulation studies, process development/optimization scale-up, and technology transfer for clinical supply/GMP manufacturing. A dynamic professional seeking a scientific role to utilize experience in the pharmaceutical industry and bring exceptional value to the position. A critical thinker with background developing and improving methodologies and procedures for superior data analysis and reporting.

  • Self-motivated and supportive teammate
  • Ability to adapt to demanding and shifting timelines
  • Meticulous attention to detail and accuracy
  • Knowledge and Set-up and operation of Buchi-290, MS-35 Spray Dryer and Korsch Tablet Press
  • Authoring of Product Development Reports and protocols
  • Knowledge of use of DSC, GC, HPLC/UPLC, CE, Subvisible particle analysis
  • Microsoft office
  • Data analysis
  • GMP Documentation
  • Technology Transfer
University of California, San Diego La Jolla, CA, Expected in 10/2013 Bachelor of Science : Pharmacological Chemistry - GPA :
Work History
Emd Millipore - Senior Associate Scientist
Gernsheim, DE, 07/2019 - Current

My partnership with Ronin Staffing provided me with the opportunity to work with Amgen in their Pivotal Drug Product Technologies Department.

  • Worked closely on biosimilar program and effectively aided in approval of Commerical Formulation Recommendation (CFR) for a high concentration formulation.
  • Utilized common detection techniques to assess common degradation pathways during protein formulation development including SE-UPLC, HIAC, MFI, CEX-HPLC, rCE-SDS.
  • Familiar with integration of formulation with process including UF/DF processes, Freeze-thaw cycling, mixing, post thaw hold, Vmax filtration.
  • Proficiency in compiling and presenting data from formulation studies.
  • Familiar with review of protocols, reports, and regulatory sections.
  • Aiding in Excipient Database Project with the goal to provide relevant and useful information in the selection of excipients for injectable protein drug products. Working towards creating a user-friendly interface for accessing this information.
Curaleaf - Associate Formulation Scientist
Saint Louis, MO, 10/2017 - 07/2019
  • Worked closely with client and BioDuro Shanghai Drug Discovery Group in utilizing innovative technology for predictive screening of several lead compounds for bioavailability enhancement (BioDuro Solution Engine) and successfully formulated a spray dried dispersion/capsule formulation
  • Experience with conducting pre-formulation studies including solubility screening and physiochemical characterization of new active pharmaceutical ingredients
  • Knowledge of utilizing Rigaku Powder X-ray Diffraction , Differential Scanning Calorimetry (DSC), SEM Analysis, and TGA for pre-formulation studies
  • Provided analytical support during development phase including non-GMP stability studies, in-process testing, and excipient compatibility studies for sold oral dosage formulations and preparation of scientific reports
  • Skilled in spray dried dispersion techniques, granulation, micronization, encapsulation, tableting, and tablet coating
  • Effectively communicated with project team and clientele about project status and provided technical rationalization/explanation
  • Experience in authoring of engineering batch records and master batch records
  • Served as subject matter expert (SME) on floor during technical transfer from development to manufacturing
  • Authored formulation development summary reports upon completion of project
Cambrex - Quality Control Scientist
Whippany, NJ, 04/2016 - 10/2017
  • Performed testing for raw material, drug product, drug substance, in-process stability testing and final release testing of manufactured products using various methods, including USP and EP methods
  • Diligently followed Standard Operating Procedures (SOPs), protocols, and cGMP notebook documentation and laboratory practices
  • Experience in Empower 3 analytical software and Microsoft office for data analysis and reporting
  • Knowledge of sink and non-sink dissolution analysis, tablet hardness, and friability testing
  • Compiled and peer-reviewed data/final reports in compliance with specifications
  • Aided in OOS investigations as well as authored lab investigation reports (LIR) and non-conforming events (NCE)• Authored stability program protocols for cGMP products as well as authored/revised analytical methods for QC use
  • Performed monthly environmental monitoring in cGMP suites following aseptic technique and compliance of safety guidelines including personal protective equipment (PPE).
  • Peer reviewed laboratory notebooks, data spreadsheets, generated stability trending forms and stability certificate of analysis
  • Provided training to new quality control chemists and interns on specific lab methods and techniques•.
Wm. B. Reily & Company, Inc - Quality Control Technician
New Orleans, LA, 01/2014 - 10/2015
  • Conducted routine analysis of raw materials, and in-process/release testing of lateral flow immunoassay products per company standard operating procedures.
  • Assisted in drafting Standard Operating Procedures (SOP’s), IQ/OQ/PQ procedures and other related manufacturing documents.
  • Calibrated and maintained all lab equipment.• Compiled data for documentation of test procedure reports.•.
Ani Pharmaceuticals - Quality Assurance Associate
Remote, OR, 10/2013 - 01/2014
  • Aided in maintaining quality systems for a global rapid diagnostic test development and manufacturing organization.
  • Responsible for assuring compliance with regulatory requirements and current good manufacturing practices put forth by the FDA by assistance in conducting audits, training programs, and reviewing/analyzing all data and documentation.
  • Assisted in laboratory control, materials management, document control, and other training in the manufacturing process of in vitro diagnostic tests.

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School Attended
  • University of California, San Diego
Job Titles Held:
  • Senior Associate Scientist
  • Associate Formulation Scientist
  • Quality Control Scientist
  • Quality Control Technician
  • Quality Assurance Associate
  • Bachelor of Science

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