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Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
Summary

• 8+ years working in a fast-paced GMP environments and delivering high quality milestones on schedule.

• Experienced in tech transfer, process development, and scale-up activities for commercial-scale biologics manufacturing.

• Evaluating empirical data to identify areas for improving process efficiencies and yields.

• Proficient in the operation, development, and validation of an variety of analytical techniques, including HPLC, GC, TOC, and LC-MS.

• Maintaining diligent GDP documentation in both hardcopy and electronic laboratory notebooks.

Education and Training
Master of Science: Biotechnology, Expected in 2011
-
Northwestern University - Evanston, IL,
GPA:
Bachelor of Science: Chemical and Biological Engineering, Expected in 2009
-
University of Colorado - Boulder, CO,
GPA:
Experience
Senior R&D Process Engineer, 09/2018 - Current
Ametek, Inc. Montvale, NJ,
  • Leading activities in the development of commercial formulation, mixing, coating, and converting processes for transdermal, dissolvable films, and other drug products.
  • Using QbD principles, planning and executing process studies for feasibility, development/characterization (DOEs), capability, qualification and validation.
  • Establishing optimum process conditions for product quality, throughput and yield.
  • Writing specifications, batch records, protocols, SOPs, process development reports, etc.
  • Maintaining accurate and complete records of development activities.
  • Supporting operations with equipment specification, qualification, and commercial manufacturing activities.
  • Interfacing and provide leadership to project teams, vendors, and clients in all activities from development to commercial scale production.
Process Engineer, 06/2017 - 09/2018
Henry Schein San Antonio, TX,
  • Contributed to process development activities for production for a monoclonal antibody product at a 10,000L bioreactor scale.
  • Provided technical guidance in commissioning and qualification activities for facility start-up efforts.
  • Served as subject matter expert and technical owner for the development and validation of all manufacturing-scale cleaning process equipment, including CIP systems, SIP circuits, glass washers, autoclaves, and IBC washers.
Lab Study Engineer II/III, 09/2012 - 05/2017
Hyde Engineering CORE Laboratory City, STATE,
  • Led consulting projects for successfully developing, optimizing, and validating a wide array of analytical test methods in GMP/GLP/ISO environments, in alignment with FDA regulations, USP methodologies, and ICH guidelines.
  • Earned responsibility for training and providing technical mentorship to junior engineers and lab analysts.
  • Performed detailed statistical analysis of experimental data and leading weekly data presentation meetings with clients.
  • Leveraged technical literature searches to identify new technologies and support analytical method improvements.
  • Page | 2 • Prepared and executed qualification protocols for laboratory equipment, in addition to instrument troubleshooting and performing scheduled preventative maintenance activities (calibration, verification, etc.).
  • Substantial experience collaborating with cross-functional teams at various client sites, including R&D, Validation, Engineering, Quality Control, Quality Assurance, Manufacturing, Operations, and Senior Management.
  • Served as Laboratory Safety Coordinator, including development of safety procedures and waste stream profiles.
  • Played a key role in the Hyde CORE Laboratory achieving ISO 9001 certification, including developing standard operating procedures, participating in internal auditing, deviation investigation, root cause analysis, continuous improvement, and risk assessment.
Technical Associate, 06/2011 - 09/2012
CBR International Corp City, STATE,
  • Served as Project Lead on consulting studies with pharmaceutical/biotech clients with regards to various chemistry, manufacturing, and controls (CMC) topics.
  • Supporting clients from a regulatory standpoint on Phase I/II/III clinical trial design, biocompatibility studies, and the development/validation of analytical test methods.
  • Conducted GLP audits of client facilities and performed GMP review of executed validation protocols.
Accomplishments
  • Selected to speak at the 2014 ISPE Annual Meeting in Las Vegas, NV. The presentation will be titled "Quantitative Image Processing for Cleaning Validation and Verification Activities" and explore the robustness of this digital image processing method and its capability to scale up to pilot-scale and full-scale production equipment.
  • Selected Speaker: 2013 ISPE Annual Meeting (Washington, DC) Selected to speak at the 2013 ISPE Annual Meeting. Presentation is titled "Visual Image Processing for Bench-Scale Cleaning Studies" and focused on a novel analytical method developed by the Hyde CORE lab for quantifying the mass of process residues on a surface via visual image processing.
  • Co-Author: "Digital Image Processing for Bench Scale Cleanability Studies"

Publication date: Jan 2015

This article is based on a presentation given at the ISPE 2013 Annual Meeting and presents an overview of a novel quantitative method utilizing imaging software combined with tightly controlled variables in lighting, angle, and distance, quantifies the amount of process residue on a surface using high-resolution photographs, to produce statistically significant data.

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Resume Overview

School Attended

  • Northwestern University
  • University of Colorado

Job Titles Held:

  • Senior R&D Process Engineer
  • Process Engineer
  • Lab Study Engineer II/III
  • Technical Associate

Degrees

  • Master of Science
  • Bachelor of Science

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